65th Annual Biosafety and Biosecurity Hybrid Conference
Professional Development Courses
Monday, September 12, and Wednesday, September 14, 2022, from 12:30 PM – 5:00 PM CDT
1V. Animal Research for Biosafety Professionals – An Introduction
Animal Research has contributed to major scientific advances in biomedical, veterinary, and environmental sciences and in public health. However, these efforts often pose significant risks to the health and safety of research and facility staff due to the wide range of species, complex experimental procedures and equipment, and facility hazards that are involved. Balancing optimal worker safety and animal welfare with research objectives yields the best results but requires a solid understanding of how animal programs are managed and an ability to identify and mitigate inherent risks. This course provides a thorough introduction to routine hazards commonly encountered in animal programs that utilize rodents, small animals, nonhuman primates, aquatics, and agricultural species, with a primary focus on identifying and managing biological, chemical, radiological, and physical hazards. The instructors are experienced laboratory animal veterinarians who are actively involved in the management, oversight, and evaluation of animal care and use programs. Topics include assessment and management of animal program hazards; universal regulations, guidelines, and quality standards that apply to animal research; duties and responsibilities of key program personnel; local oversight systems; best practices that enhance the quality of animal care; and strategies for biosafety professionals to develop and maintain effective partnerships with program staff and institutional animal care and use committee members. Opportunities will be provided to apply new knowledge and skills through group interactive activities and problem-solving sessions.
Objectives:
- Review basic hazard identification and risk assessment techniques relevant to research involving live animals
- Summarize the governing regulations and guidelines that pertain to the care and use of research animals, recognizing the difference between “regulatory requirements” and “best practices” that relate to performance-based standards
- Identify successful strategies for working effectively with animal program personnel on common research safety issues
Suggested Background: None
Target Audience: New Biosafety Professionals, All Safety Professionals, Laboratory Workers
Audience Level: Basic
|Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
COURSE FACULTY
Dr. Susan Harper received her DVM from Louisiana State University and worked in large animal practice for several years before enrolling in a post-doctoral residency in comparative medicine at the Penn State University College of Medicine. She served on the Penn State faculty for 2 years following graduation, before accepting a position with the National Institutes of Health (NIH). She has worked at several different Departments and Agencies during her federal career and currently serves as the Deputy Director for the NIH Office of Animal Care and Use in Bethesda, MD. She is a diplomate of the American College of Laboratory Animal Medicine (ACLAM) and the American College of Veterinary Preventative Medicine (ACVPM); a Registered Biosafety Professional (RBP) through the American Biological Safety Association (ABSA); and serves on the AAALAC International Council on Accreditation.
Dr. Lesley A. Colby is a Professor at the University of Washington (UW) in the Department of Comparative Medicine (DCM). In addition to her clinical, instructional, and research activities, her responsibilities include oversight of the daily operations of DCM-managed animal research facilities as well as coordination of the renovation, design, and construction of animal research facilities. Dr. Colby also serves as Director of the UW BSL3/ABSL3 Select Agent Facility and is a member of the UW Institutional Biosafety Committee (IBC). Dr. Colby earned her BS in Animal Science from Virginia Tech and both her DVM and MS from the Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM). After working as a small animal practitioner in Montana, she returned to VMRCVM to complete a postdoctoral training program in Laboratory Animal Medicine. She then joined the faculty at the University of Michigan’s Unit for Laboratory Animal Medicine for 10 years during which time she served as Assistant Director as well as Director of their clinical laboratory animal medicine post-doctoral training program and Director of the University’s BSL3/ABSL3 Select Agent Facility. Dr. Colby is board certified by the American College of Laboratory Animal Medicine and is a member of the AAALAC International Council on Accreditation. She frequently collaborates with health and safety professionals in numerous aspects of her position and has special interest in facility design, biological containment, teaching, and occupational health and safety.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Monday – Friday, September 19-23, 2022 from 10:00 AM – 11:30 AM CDT
2V. IATA Infectious Substance Shipping Certification
This course is appropriate for those who have some experience with infectious substance handling or shipping but may not have been certified within the past 3 years and those with little to no previous training. The course utilizes several facilitated learning activities. The course will be administered in five, 1.5-hour virtual sessions, Monday – Friday. There will be group discussions and interactive exercises focused on the essential areas of infectious substance shipping. New IATA requirements for competency assessment will be administered daily in short interactive homework assignments, and an online exam. Participants will mark, label, package, and complete documentation for infectious substance shipments (Category A, Category B, and Exempt Patient Specimens), and review applicable regulations with a focus on IATA. Additional US DOT differences will also be addressed. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. Participants have both an online exam (score at least 80%) and practical exercises to complete to demonstrate competency. Successful completion of the course will qualify participants for IATA/DOT certification.
Objectives:
- Review and understand shipping regulations for both air and ground with a particular focus on 49 CFR US DOT and IATA air regulations
- Conduct risk assessment and be able to properly classify and identify infectious substances for transport purposes
- Package, mark/label and prepare documentation for shipments of infectious substances to meet regulatory requirements for air and ground shipments
Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals
Audience Level: Basic
Course Length: 8 hours (classwork and five 1.5-hour live sessions)
COURSE FACULTY
Eric Cook is the corporate biosafety officer for Sandia National Laboratories and a Principal Member of the Technical Staff in the Global Chemical Biological Threat Reduction Program where his work focuses on promoting global laboratory biorisk management (BRM). Most of his focuses on biorisk management training and trainer/curriculum development; laboratory risk assessments; and mentoring biorisk management advisors. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he established the biosafety program at the college. He was a Biosafety Officer at the Massachusetts Institute of Technology (MIT) for six years prior to that. While at MIT, Eric completed his Master’s Degree in Public Health at Boston University with a focus on Environmental Health. Eric has a B.S.in Molecular Biology from Brigham Young University. He is has been a member of ABSA International since 1997 and recently received the prestigious John H. Richardson Special Recognition award for contribution to the profession of biosafety. He has been a Certified Biosafety Professional (CBSP) since 2005.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Monday, October 3 and Friday, October 7, 2022, from 10:30 AM – 3:00 PM CDT
3V. Articulating the Value of Your Biosafety Program
A recurrent challenge confronting biosafety professionals is the ability to garner necessary program resources to achieve desired goals and objectives. The basis for this difficulty is that, on a good day in the world of biosafety, “nothing happens”. The underlying challenge is that upper management may not fully appreciate or understand all of the effort and resources that went into making “nothing happen”. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course focuses on some key management approaches and techniques that can be used within biosafety programs to help improve stakeholder understanding, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques presented will be displayed for review and discussion. Ample time will be provided throughout the course for participant interaction and inquiries.
Objectives:
- Identify various biosafety programmatic measures and metrics that should be captured and communicated
- Restate the techniques that can be used for displaying biosafety data in ways that others can readily understand and appreciate it
- Describe how biosafety programs can assist with other basic safety program needs to help avoid the notion of program duplication of efforts and to improve safety and client satisfaction levels
Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate
Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
COURSE FACULTY
Robert Emery, DrPH, CHP, CIH, CBSP, CSP, CHMM, CPP, ARM is Vice President for Safety, Health, Environment & Risk Management for The University of Texas Health Science Center at Houston (UTHealth Houston) and Professor of Occupational Health at the University of Texas School of Public Health.
Kristin King, DrPH, CPH, CBSP, CHSP, CIC is the Biological Safety Program manager within Environmental Health & Safety at The University of Texas Health Science Center at Houston (UTHealth Houston).
Scott Patlovich, DrPH, CIH, CSP, CBSP, CHMM, CPH is the Assistant Vice President of Environmental, Health & Safety at The University of Texas Health Science Center at Houston (UTHealth Houston) and an Instructor at The University of Texas School of Public Health (UT SPH).
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Friday, February 17, 2023, from 10:00 AM – 3:00 PM CDT
4V. BSL-3 Design and Operations: Lessons from the Trenches
Many academic institutions have built Biosafety Level 3 containment laboratories over the past 15 years, anticipating these facilities to be an instrument to attract researchers and stay on the cutting edge of science. Most of these labs have been successfully operated since construction while others have become dormant due to various factors ranging from poor initial design, construction issues, engineering flaws, lack of operational staff, lack of funding for the operation of the lab, and ongoing maintenance costs. When planning and designing these facilities, it is essential to consider the costs and other needs (e.g., staffing and procedures) associated with maintaining these facilities over the long term. This course will present lessons learned by the instructor from experiences related to the design, operation, and maintenance of a variety of high-containment laboratories (BSL-3, ABSL-3, etc.). Lab design parameters, utility requirements, maintenance and operation best practices, and tips and tricks will be shared with participants through lectures, small group discussions, and case studies.
Objectives:
- Restate the components and requirements for managing a BSL-3 facility
- Summarize the potential pitfalls and mistakes in lab design and operations
- Describe the best practices in preventative maintenance for BSL-3 facilities
Suggested Background: Fundamentals of Biosafety, Biosafety Level 3 Design and Operations
Target Audience: All Safety Professionals, Facilities Maintenance Staff
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 60-minute break)
COURSE FACULTY
Matt is the Biosafety Officer and Responsible Official (RO) at the University of Nebraska Lincoln (UNL), where he has been since 2009. His duties include management of the biosafety program at UNL, serving as RO for UNL’s Select Agent Program as well as serving on the IBC, IACUC and Plant Growth Facility committees. He attended Dana College in Blair, NE (1994-1998) for his undergraduate studies and double majored in Biology and Chemistry. He earned his PhD in Chemical Biology from Washington University in St. Louis in 2005. His graduate work focused on molecular recognition of the main light sensing pathway in the human eye and understanding the forces and characteristics involved in the interaction between Rhodopsin (a G-protein coupled receptor) and its cognate G-protein,transducin. He completed a two-year post-doctoral fellowship also at Washington University designing peptide-based scaffolds for site-directed targeting of lipid nanoparticles carrying both imaging agents and therapeutic compounds. He got his start in biosafety through a post-doctoral fellowship in biosafety at Washington University in St. Louis (2008-2009) under the mentorship of Susan Cook. He has been an ABSA member since 2008, currently serving as Chair of the ABSA E-communications Committee (2015-present), a member of the ABSA Scientific Program Committee (2018–present), ABSA Nominating Committee (2020), and Chair of the Local arrangements Committee for the 2023 ABSA Conference. He has been active in the Midwest Area Biosafety Network (MABioN) affiliate since 2008, having held positions as Councilor-at-Large (2012-2014), President Elect (2014-2016), and President (2016-2018) and Past-President (2018-2020). He obtained his RBP certification in 2015 and CBSP certification in 2019.At UNL Matt has been involved with numerous lab design and renovation projects including BSL-1, BSL-2 and BSL-3 laboratories. He has completed both ABSA pre-conference courses on Engineering for the Biosafety Professional as well as completed BSL-3 and ABSL-3 training courses from UTMB. As the RO he has been intimately involved with the operations of UNL’s BSL-3 laboratories and participated in every annual certification since the first lab opened in 2009.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Thursday, September 29, 2022, from 10:00 AM – 3:00 PM CDT
5V. Laboratory Transition: Planning for the Inevitability of Change
Life sciences facilities are expensive and require long timelines for facility change. The last few years have emphasized the importance of adaptable, flexible solutions to accommodate changing needs for laboratory operations. Everyone has experienced the trials of transition during the global COVID-19 pandemic. A changing environment necessitates rapid shifts in programs; as we move into a post-COVID world, we can expect additional challenges, both predictable and unforeseen. Given the speed of change and the expectation to react quickly and decisively, designing and implementing laboratory programs addressing the current and future requirements is key. This course will discuss the methods for assessing needs and planning for change, including components for consideration in both facility design and science operations. Discussions will be focused on the development of new facilities and programs with the inevitability of change in mind; applying lessons learned from experience in the field; identifying risks, opportunities, and strategies for a resilient program that is able to respond to current and future challenges. The course will walk through a series of scenarios to discuss program redirection with and without facility renovation and participants will have the opportunity to identify actions that will prepare their own organizations for potential change.
Objectives:
- Discuss recent emphasis on flexibility in program design, including defining “flexibility” for different organizations
- Review methods for assessing needs and planning for change as it occurs
- Identify risks, opportunities, and strategies for a resilient program that is able to respond to current and future challenges
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Managers, Program Managers, Institutional Leadership
Audience Level: Intermediate
Course Length: 4 hours (one 4-hour live session with a 60-minute break)
COURSE FACULTY
Lauren Richardson has a background in veterinary medicine and public health. With experience in large and small animal clinical medicine, food safety and defense, and infectious disease, Dr. Richardson has supported projects in Africa, Central Asia, Europe, Middle East, and North America. As Director of Science and Technology in the Merrick Life Sciences Business Unit, she provides technical subject matter advisory support, training, and management for domestic and international work focused on laboratory operational and transition planning, risk and threat management, and health systems strengthening efforts. Prior to this work, she practiced equine and mixed large animal clinical veterinary medicine in Virginia and North Carolina. Additionally, Dr. Richardson serves as a veterinarian in the United States Army Reserve. Dr. Richardson earned a Bachelor of Science in biology from the University of Virginia, a Doctor of Veterinary Medicine from the VA-MD Regional College of Veterinary Medicine, a Master of Public Health from the Johns Hopkins Bloomberg School of Public Health, and is a diplomate of the American College of Veterinary Preventive Medicine.
Ryan Gregory has a background in mechanical engineering and facility commissioning specializing in life sciences laboratories. As the leader of laboratory projects across Canada and internationally, Ryan has participated in and led interdisciplinary teams of designers and lab users from project inception through design, commissioning, licensing and ongoing operational support. Through this work, Ryan has developed a strong appreciation for the impact of facility design on operations and vice versa along with an appreciation for how to create laboratory adaptability and resiliency in both new and existing facilities.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Friday, October 14, 2022, 8:00 AM – 5:00 PM
1. Basic Risk Assessment
Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the practices and containment necessary to avoid exposure to hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary to perform risk assessments for working safely with pathogens (human and animal) and rDNA (genetically modified organisms or viral vectors). Using case studies, participants will work together to conduct risk assessments by determining the hazards involved; the appropriate questions to ask to address the potential risks associated with the intended activities and make recommendations on appropriate containment and practices required to work safely. Each group will present their conclusions from the activity.
Objectives:
- Identify and list determinants for assessing risk (host, environment, agent)
- Complete the steps of a risk assessment and determine steps to manage risk (mitigation)
- Identify resources and references for risk assessment/management
Suggested Background: Fundamentals of Biosafety
Target Audience: New Biosafety Professionals, Laboratory Workers
COURSE FACULTY
Angela Birnbaum, MPH, serves as the Executive Director of Biosafety, Biocontainment Operations, and Quality Assurance at Tulane University, and oversees a large university-wide biosafety program research including recombinant DNA, clinical trials, and research with high risk pathogens. She has years of experience working in academic institutions, including New York Medical College, Massachusetts Institute of Technology, and Harvard University as well as contract research organizations. Angela has a proven track record of biosafety and biosecurity program implementation, risk assessment, team building and integration, and a strong capacity to build and rebuild sustainable biosafety programs for complex research programs. She also has a strong history of productive interactions with local, state, and federal regulatory agencies.
Angela is a Registered Biosafety Professional, Certified Hazardous Material Manager, Certified Biosafety Professional, and a Specialist Microbiologist in the National Registry of Certified Microbiologists. She brings over 20 years of experience implementing compliance services to BSL-1/ ABSL-1, BSL-2/ ABSL-2, BSL-3/ABSL-3, and BSL-3/ABSL-3-enhanced containment facilities for animal models including mouse, rat, rabbit, pig and non-human primates.
Dr. Gamble is the Associate Director, Biorisk Management Programs within Science & Technology in the Life Sciences practice at Merrick. Rachel has 15+ years of experience directing and managing safety programs for two biomedical research institutions with focused experience in biological safety and select agent regulations. She previously served as the Director of the Office for Environmental Safety as well as the director for the high containment/select agent research facility at Baylor College of Medicine. Dr. Gamble has recently worked on the stand-up of the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS, on behalf of the U.S. Department of Homeland Security and the U.S. Department of Agriculture in addition to various projects for government and academic institutions both domestic and international. She holds a doctorate in public health, CBSP and RBP certifications, held previous Southern Biosafety Association (SBA) positions (treasurer, vice president, president, and past president), current vice president of SBA, serves as an ad hoc
Katie George is a Biosafety Professional from Montana. She holds a BS in Biology and a PhD in Biochemistry. After obtaining her PhD, she was a post-doctoral fellow at the National Institutes of Health in the field of mycobacterial pathogenesis. Katie then became a faculty member at the University of Montana where she researched organophosphate toxicology. Currently, Katie is an Associate Partner and Human Gene Therapy Biosafety Officer with Clinical Biosafety Services and works with clinics and hospitals in the US and Canada to prepare for IBC review of human gene therapy clinical trials.
Dave is currently a Safety and Occupational Health Manager for the Center of Veterinary Medicine at the FDA. Prior to his current position, he served as the Program Director of the National Biosafety and Biocontainment Training Program at the National Institutes of Health. Before that, he served as the Biological Safety Officer at the United States Army Medical Research Institute of Infectious Diseases (2012-2021). Prior to working at USAMRIID, he was a fellow in the National Biosafety and Biocontainment Training Program. Proceeding the fellowship, he graduated with his B.S. in Biochemistry from Virginia Tech and his Ph.D. in Toxicology from UNC-Chapel Hill. Dave has been an ABSA member since 2010 and has previously served as the Chair of the Pre-Conference Course Committee as well as Chair of the Training Tools and Resources Committee in addition to being a member of the Standards Committee, Professional Development Team and Select Agent Community Advisory Committee for ABSA. He has recently been named Co-Chair of the ABSA Ambassadors Committee. Locally, Dave has previously been a Councilor for the Chesapeake Area Biosafety Association as well has chair of the Scientific Program Committee for its annual symposium. Dave is also currently a member of the Exam Development Committee for the CBSP exam and previously served as Chair of the DoD Biosafety and Scientific Review Panel. Dave is certified as a biosafety professional through both ASM and ABSA.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Friday, October 14, 2022, 8:00 AM – 5:00 PM
2. Keeping it Going: Maintaining and Improving a Select Agent Program over the Long Term
Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable by interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great program. A proactive approach can minimize the impact of new requirements and reduce the duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing Select Agent program, including strategies for anticipating and responding to new requirements. The focus will be on U.S. Select Agent requirements, although a section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class participants during open discussions. Topics will include select agent program history; effective oversight practices; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; implementation of the recent inactivation requirements, including strategies for investigating inactivation “failures;” and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating the application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.
Objectives:
- Identify strategies for: efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements and being able to efficiently implement necessary changes and preparing for and responding to regulatory inspections
- Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns in accompanying exercises
- Summarize inactivation requirements and identify successful strategies for compliance
Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
COURSE FACULTY
Shelley Jones, MS, RBP, is the Director of Biological Safety and Responsible Official at Northern Arizona University. She received her B.S. from Illinois State University and her M.S. from Arizona State University, both in environmental disciplines. Shelley has over 30 years of diverse experience in environmental health and safety. She has been a Responsible Official/Alternate Responsible Official for 18 years.
Amy Vogler, PhD, RBP is an Associate Director at the Pathogen and Microbiome Institute (PMI) at Northern Arizona University (NAU). She has worked at PMI since 1997 as a researcher and has been responsible for managing their BSL-3 Select Agent laboratory since 2009. She received her B.S. in Microbiology and Chemistry in 1999 and her Ph.D. in Biology in 2003 from NAU and is an author on 40 publications in the field of population genetics and molecular epidemiology of bacterial pathogens. She continues to conduct research on Yersinia pestis while also managing the BSL-3 laboratory. She received her RBP in 2012.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Friday, October 14, 2022, 8:00 AM – 5:00 PM
3. Part I – Quality Management System for Biorisk Management: ISO 35001:2019
Biorisk Management is a comprehensive approach to assess, control, mitigate, and ultimately manage risks associated with biological materials. Historically, and from a laboratory perspective, this has been done primarily under the umbrella of certain biosafety and biosecurity practices and principles. However, in today’s environment, this mostly reactive approach cannot be considered sufficient anymore. Consequently, a much more comprehensive and proactive management system approach is required to deliver on the expectations for safe, secure, and ethical research and development involving biological agents and systems. This comprehensive two-part workshop will introduce the aspects and components of a quality management system based on ISO 35001:2019, as it relates to biorisk management as well as discuss specific implementation strategies. By utilizing specific quality management tools, approaches and concepts, laboratories will advance in their overall compliance, stakeholder satisfaction, and move towards a proactive, continuously improving biorisk management system. This will allow for addressing future needs and expectations for safe, secure, and ethical research and development involving biological agents and systems.
In Part I, participants will discuss the concept of a quality management system and how it relates to ISO 35001:2019. Concepts like QMS, quality key principles, PDCA, logic model, and risk management will be addressed and applied within practical hands-on exercises during the workshop. By understanding the key principles behind ISO 9000/9001, participants will be able to better understand the structure and components of ISO 35001:2019 and its application and/or implementation within the laboratory setting. Included in the cost of the workshop, participants will receive an electronic, licensed copy of ISO 35001:2019.
This course is now full!
Objectives:
- Identify and describe the relationship between ISO:9001 and ISO:35001
- Restate the principles of a quality management system and explain how it applies to biorisk management
- Name and apply the key components of risk management
- Describe the advantages and challenges of a biorisk management system
Suggested Background: Risk Assessment
Target Audience: All Safety Professionals, All Biosafety Professionals, Laboratory Managers, Directors and Executives
COURSE FACULTY
As the Executive Director and founder of Biorisk International, Dr. Stefan Wagener brings with him almost 30 years of international experience in the fields of biosafety, biosecurity, and bioethics as well as executive management. He retired as Director General from the Government of Canada in 2019, after having worked for Health Canada, the Public Health Agency of Canada, the Canadian Food Inspection Agency, and the Canadian Grain Commission. These years of public service provided him with a unique insight and experience in the human health and agricultural sector.After obtaining his MSc and PhD in Microbiology (Germany), he joined Michigan State University (USA) in 1989 working as a research scientist, health and safety professional and biocontainment specialist. From 2001 to 2006, as the Chief Administrative Officer (CAO), he managed all operational aspects of Canada’s Biosafety Level 4 public health and animal containment facility the “Canadian Science Centre for Human and Animal Health” in Winnipeg, Manitoba, Canada. Starting in 2006, as the Scientific Director, he developed an extensive biorisk science, training and research program at the Centre while holding a joint appointment at the University of Manitoba.In 2007 & 2012, Dr. Wagener was the Chair of the European Committee for Standardization (CEN) workshops which developed the first international laboratory biorisk management standard (CWA 15793:2008) and associated guidance document (CWA 16393:2012). These documents were the foundation of the new ISO 35001:2018 management system standard for Biorisk Management. Prior to joining the Canadian Grain Commission in January of 2014, he assisted the Department of Foreign Affairs Canada, the World Health Organization, the Canadian Space Agency and numerous laboratories and organizations in Eastern Europe, Africa, and Asia as an adviser on scientific programs, laboratory quality management systems, operations, biorisk management, and bioethics. He is an internationally recognized speaker, trainer, facilitator, and coach. As a certified ISO 17025, OHSAS 18001, and ISO 9001 lead auditor, he is also providing laboratory, quality management, and biorisk & bioethics assessment services to international clients. He currently serves on the board of the Global Biorisk Advisory Council (GBAC). Stefan Wagener is a recipient of the Everett Hanel, Jr. Presidential Award (USA), a Past-President of the American Biosafety Association (ABSA) and a fellow of the Alexander von Humboldt Foundation (Germany).
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Saturday, October 15, 2022, 8:00 AM – 5:00 PM
4. Engineering for the Biosafety Professional—Part I
Biosafety professionals (BSOs) need to be involved and knowledgeable in the operation, maintenance, and certification of their biocontainment facilities and building systems. The BSO is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course provides basic engineering principles that are useful in the planning, design, and operation of a BSL-3 facility and is intended to fill the gap by providing basic knowledge for understanding the processes used in the planning, design, construction, maintenance, and operation of a BSL-3 laboratory. For the BSO to participate in these activities, they need to understand engineering fundamentals, develop skills to ask questions in engineering terms, and possess the confidence to question the answers. This is the first course of a two-part series offered in alternating years. Part I of the course will provide information relevant to BSL-3 facilities for the determination of air change rates, define HVAC containment boundaries, interpret design drawings, understand HEPA filtration, provide an introduction to determining room heat loads and ventilation rates, provide concepts in directional airflow and room pressure differentials as well as an introduction to HVAC components. There will be presentations on planning, design (with a checklist), construction oversight, commissioning, certification/validation/ANSI Z9.14 Standard, maintenance, and operations. Upon course conclusion, the participants should have the knowledge to better understand engineering issues in the planning, design, construction, commissioning, certification/validation, and post-occupancy of biocontainment facilities, be able to formulate informed questions, be able to interact with maintenance personnel and integrate facility operations with the biosafety program.
Objectives:
- Discuss the engineering principles, design, and construction process of a BSL-3 laboratory in order to identify potential problems before construction begins
- Identify the phases and the strategies of a BSL-3 laboratory design
- Describe the elements of a quality assurance program
Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals, Operations and Maintenance Personnel
COURSE FACULTY
Mr. Juan Osorio provides consulting in engineering with a focus in high- and maximum containment laboratories (BSL-3 and BSL-4), biomedical facilities, hospitals and research facilities. In this role, he consults with clients regarding laboratory planning, programming, commissioning, validation and third-party certification activities for significant Biocontainment, Laboratory, Vivarium, Safety and Healthcare projects. Mr. Osorio has consulted, reviewed, validated and certified biocontainment laboratories, mission critical government institutions, vivaria, and world-class medical facilities. He has vaexperience in the high and maximum containment field and participates on biocontainment projects in the United States, Asia and South America. Mr. Osorio contributes to the design, construction, validation, third-party certification and maintenance of such facilities. He has served frequently as a consultant for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for industrial engineering issues in biocontainment, general laboratory, hospital and vivarium projects. He has assisted in the development of high- and maximum containment government guidelines and regulations for the NIH.
Mr. Theodore J. Traum is a Professional Engineer with over thirty-five years of experience in engineering with a focus in high- and maximum containment laboratories (BSL-3, ABSL-3 and BSL-4), biomedical facilities, hospitals and research facilities. In this role, he consults with clients and oversees laboratory planning, programming and commissioning, and performs validation and third-party certification activities for significant biocontainment, laboratory, vivarium, safety and healthcare facilities worldwide. Mr. Traum specializes in Heating, Ventilation and Air Conditioning (HVAC) systems, electrical systems, effluent decontamination systems, containment devices, sustainable design, constructability, biosecurity, engineering risk analysis, process flow, maintenance of high containment systems and biomedical waste processing. Mr. Traum served on the Biosafety for Microbiological and Biomedical Laboratories (BMBL), 5th Edition revision committee and the NIH Design Policy and Guidelines revision committee. He has co-authored the NIH BSL-3 Laboratory Certification Guidelines. Mr. Traum is currently participating in the development of the maximum containment certification guidelines for the National Institutes of Health (NIH). In addition, Mr. Traum was a contributor to the CEN Workshop 55 guidance document on biorisk management. He also served on a committee that developed the ANSI Standard: Z9.14 Certification for BSL-3 Laboratories. Mr. Traum has provided assistance to the Singapore Ministry of Health in the development of their regulations.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Saturday, October 15, 2022, 8:00 AM – 5:00 PM
5. BSL-3 Operations and Management
This course will review the important aspects of BSL-3 Operations and Management from two points of view; “hardware” (i.e., facilities & equipment issues) and “software” (i.e., administrative controls). It will cover various aspects you need to consider in order to operate a BSL-3 facility, such as training, maintenance support, occupational health, waste management, maintenance, performance verification, and emergency response. The instructors will encourage interaction and the exchange of experiences among the participants. Regulatory aspects from any specific country, or planning, design, or construction-related issues will not be covered.
Objectives:
- Describe the elements of BSL-3 Operations and Management (risk management, primary barriers, annual performance verification, emergency response, etc)
- Recognize institutional, management, and user responsibilities
- Summarize approaches to developing manuals, SOPs, and training
Suggested Background: Basic Risk Assessment and familiarity with BSL-3 Concepts
Target Audience: Safety Professionals, BSL-3 Managers, Containment Engineers, Lab and Scientific Directors
COURSE FACULTY
Paul Jennette holds Bachelor’s and Master’s Degrees in Environmental Engineering from Cornell and the University of Massachusetts, respectively, and is both a Registered Professional Engineer and a Certified Biological Safety Professional. Since 1999, he has held the position of Biosafety Engineer at the Cornell College of Veterinary Medicine and has also been the Director of Biocontainment Operations there since 2013. Paul’s responsibilities include:•design, verification, operation, decontamination, and program management related to Cornell’s BSL-3, ACL-3, and ABSL-3 facilities, which include both research & diagnostic laboratories as well as a BSL-3 large animal necropsy; training all Cornell BSL-3 scientific and support staff and providing direct, in-containment support for BSL-3 diagnostic operations; directing the operations of Cornell’s medical and pathological waste treatment facility, which includes a 5,000-lb/batch carcass digester; serving on Cornell’s Institutional Biosafety Committee and directing the Cornell Vet College Rabies Risk Management Program. Paul serves on biosecurity teams for Select Agent Labs at the Cornell Vet College and provides technical support for the College’s effluent decontamination systems. He served as the American Biological Safety Association’s representative on the ANSI committee to develop a national standard for the verification of BSL-3 facility performance, is a reviewer and lead author of a technical column for the Applied Biosafety journal, and is a member of ABSA’s Professional Development Team. He is a former co-chair of ABSA’s Principles & Practices of Biosafety class as well as a regular instructor for BSL-3 courses offered by the Eagleson Institute and ABSA. In addition to his position at Cornell, Paul provides biocontainment operations consulting services to a variety of academic, governmental, and pharmaceutical clients.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Saturday, October 15, 2022, 8:00 AM – 5:00 PM
6. Part II – Biorisk Management Systems: Implementation Strategies for ISO 35001-2019
Biorisk Management is a comprehensive approach to assess, control, mitigate, and ultimately manage risks associated with biological materials. Historically and from a laboratory perspective, this has been done primarily under the umbrella of certain biosafety and biosecurity practices and principles. However, in today’s environment, this mostly reactive approach cannot be considered sufficient anymore. Consequently, a much more comprehensive and proactive management system approach is required to deliver on the expectations for safe, secure, and ethical research and development involving biological agents and systems. This comprehensive two-part workshop will introduce the aspects and components of a quality management system based on ISO 35001:2019, as it relates to biorisk management as well as discuss specific implementation strategies. By utilizing specific quality management tools, approaches and concepts, laboratories will advance in their overall compliance, stakeholder satisfaction and move towards a proactive, continuously improving biorisk management system. This will allow for addressing future needs and expectations for safe, secure, and ethical research and development involving biological agents and systems.
Part II of this workshop series will build on the concepts introduced in Part 1 and discuss specific implementation strategies and tools. Through hands-on group exercises, we will take a closer look at the concept of gap analysis, documentation control, process mapping, and audits. In addition, we will discuss specific implementation steps for ISO:35001:2019 and analyze the key clauses of ISO 35001 in more detail.
This course is now full!
Objectives:
- Describe the importance of gap analysis and document control
- Name critical components of an SOP
- Map specific processes within the work environment and identify the necessary requirements for internal audits
- Successfully initiate the implementation of individual clauses of ISO 35001-2019 and apply the principles of a QMS
Suggested Background: Part I—Quality Management System for Biorisk Management: ISO 35001:2019 or participation in the 2021 or 2022 ABSA webinar (Introduction to Biorisk Management Systems and ISO 35001)
Target Audience: All Safety Professionals, All Biosafety Professionals, Laboratory Managers, Directors, and Executives
COURSE FACULTY
As the Executive Director and founder of Biorisk International, Dr. Stefan Wagener brings with him almost 30 years of international experience in the fields of biosafety, biosecurity, and bioethics as well as executive management. He retired as Director General from the Government of Canada in 2019, after having worked for Health Canada, the Public Health Agency of Canada, the Canadian Food Inspection Agency, and the Canadian Grain Commission. These years of public service provided him with a unique insight and experience in the human health and agricultural sector.After obtaining his MSc and PhD in Microbiology (Germany), he joined Michigan State University (USA) in 1989 working as a research scientist, health and safety professional and biocontainment specialist. From 2001 to 2006, as the Chief Administrative Officer (CAO), he managed all operational aspects of Canada’s Biosafety Level 4 public health and animal containment facility the “Canadian Science Centre for Human and Animal Health” in Winnipeg, Manitoba, Canada. Starting in 2006, as the Scientific Director, he developed an extensive biorisk science, training and research program at the Centre while holding a joint appointment at the University of Manitoba.In 2007 & 2012, Dr. Wagener was the Chair of the European Committee for Standardization (CEN) workshops which developed the first international laboratory biorisk management standard (CWA 15793:2008) and associated guidance document (CWA 16393:2012). These documents were the foundation of the new ISO 35001:2018 management system standard for Biorisk Management. Prior to joining the Canadian Grain Commission in January of 2014, he assisted the Department of Foreign Affairs Canada, the World Health Organization, the Canadian Space Agency and numerous laboratories and organizations in Eastern Europe, Africa, and Asia as an adviser on scientific programs, laboratory quality management systems, operations, biorisk management, and bioethics. He is an internationally recognized speaker, trainer, facilitator, and coach. As a certified ISO 17025, OHSAS 18001, and ISO 9001 lead auditor, he is also providing laboratory, quality management, and biorisk & bioethics assessment services to international clients. He currently serves on the board of the Global Biorisk Advisory Council (GBAC). Stefan Wagener is a recipient of the Everett Hanel, Jr. Presidential Award (USA), a Past-President of the American Biosafety Association (ABSA) and a fellow of the Alexander von Humboldt Foundation (Germany).
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Saturday, October 15, 2022, 8:00 AM – 5:00 PM
7. Animal Research for Biosafety Professionals – Advanced
This course builds on general principles presented in the introductory class (Animal Research for Biosafety Professionals – An Introduction) and focuses on complex animal and research-based scenarios that present unique and challenging safety concerns. Topics include viral vectors; patient-derived xenografts (PDX) and humanized animals; nanoparticles; cytotoxic drugs; arthropod containment within a vivarium; aquatic animal models; wildlife species; biosecurity challenges; facility design; animal imaging; high-containment; animal program disaster planning; and management of chemical and biological wastes (e.g., bedding and carcasses). Proven strategies for optimizing safety program outcomes through constructive partnerships between safety professionals and key animal program representatives will be presented. The course will be highly interactive and focus on problem-based learning through scenarios and interactive exercises that illustrate “real world” examples. Participants will practice developing strategies to identify potential hazards, assess the magnitude and extent of induced risks, and implement effective and cost-efficient control measures that protect the safety of workers, animals, and the environment. Participants will work in small groups and utilize an online survey tool during larger group discussions.
Objectives:
- Review hazard identification and risk assessment strategies as they pertain to a variety of animal models, including aquatics and wildlife, and complex animal facility environments
- Apply effective control strategies for unique animal hazards through proactive experimental design and facility management procedures
- Identify ways safety professionals can partner with animal program personnel to address new and emerging safety issues associated with animal-based research
Suggested Background: A basic understanding of, and experience with, identifying and managing common hazards found in animal research (Animal Research for Biosafety Professionals – An Introduction)
Target Audience: Experienced Biosafety Professionals, All Safety Professionals, Laboratory Workers
COURSE FACULTY
Dr. Lesley A. Colby is a Professor at the University of Washington (UW) in the Department of Comparative Medicine (DCM). In addition to her clinical, instructional, and research activities, her responsibilities include oversight of the daily operations of DCM-managed animal research facilities as well as coordination of the renovation, design, and construction of animal research facilities. Dr. Colby also serves as Director of the UW BSL3/ABSL3 Select Agent Facility and is a member of the UW Institutional Biosafety Committee (IBC). Dr. Colby earned her BS in Animal Science from Virginia Tech and both her DVM and MS from the Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM). After working as a small animal practitioner in Montana, she returned to VMRCVM to complete a postdoctoral training program in Laboratory Animal Medicine. She then joined the faculty at the University of Michigan’s Unit for Laboratory Animal Medicine for 10 years during which time she served as Assistant Director as well as Director of their clinical laboratory animal medicine post-doctoral training program and Director of the University’s BSL3/ABSL3 Select Agent Facility. Dr. Colby is board certified by the American College of Laboratory Animal Medicine and is a member of the AAALAC International Council on Accreditation. She frequently collaborates with health and safety professionals in numerous aspects of her position and has special interest in facility design, biological containment, teaching, and occupational health and safety.
Dr. Susan Harper received her DVM from Louisiana State University and worked in large animal practice for several years before enrolling in a post-doctoral residency in comparative medicine at the Penn State University College of Medicine. She served on the Penn State faculty for 2 years following graduation, before accepting a position with the National Institutes of Health (NIH). She has worked at several different Departments and Agencies during her federal career and currently serves as the Deputy Director for the NIH Office of Animal Care and Use in Bethesda, MD. She is a diplomate of the American College of Laboratory Animal Medicine (ACLAM) and the American College of Veterinary Preventative Medicine (ACVPM); a Registered Biosafety Professional (RBP) through the American Biological Safety Association (ABSA); and serves on the AAALAC International Council on Accreditation.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Saturday, October 15, 2022, 8:00 AM – 12:00 PM
8. Introduction to Biosafety in the Clinical Setting
The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Topics covered include common issues and lessons learned pertaining to clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs, and waste disposal facilities; PPE, disinfection, risk assessments, and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel, and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials. The course will conclude with a focus on clinical trials including the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines, and gene therapy. The course is designed to be highly interactive with discussions, surveys, and team exercises.
Objectives:
- Apply biosafety principles in the clinical setting
- Perform risk assessments and identify gaps in occupational safety in the clinical setting
- Discuss the regulatory oversight structure for clinical trials and the developmental process for investigational products
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals, Research Administration, Clinical Professionals
COURSE FACULTY
Dr. Eisenman serves as Executive Director of Biosafety Services for Advarra where he directs the organization’s IBC service, focusing largely on clinical trials involving human gene transfer. Prior to joining Advarra, he served as Biosafety Officer at UNC Chapel Hill and the Medical University of South Carolina. Dr. Eisenman holds a PhD in Molecular Biology and Immunology from Augusta University as well as various professional certifications in biological safety, including the Registered Biological Safety Professional (RBP) and Certified Biological Safety Professional (CBSP) certifications through the American Biological Safety Association (ABSA) and as a Specialist Microbiologist in Biological Safety (SM(NRCM)) through the American Society for Microbiology (ASM) National Registry of Certified Microbiologists (NRCM). He also holds a Regulatory Affairs Certificate: Pharmaceuticals from the Regulatory Affairs Professionals Society (RAPS). He is a devoted longtime educator, having taught microbiology at the undergraduate and graduate levels. He is currently co-chair of the ABSA Scientific Planning Committee and leads the Advanced Biosafety Training committee. He regularly speaks at clinical research conferences.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 8:00 AM – 5:00 PM
10. Overview of Plant Biotechnology, Field Trial Basics, Arthropod Research, and Husbandry
Plant biotechnology is used to create gene-based solutions for weed, disease, pest control, and yield enhancement. Field trials in plant biotechnology are designed to test the promising new plants developed by biotechnology in a situation similar to the actual growing conditions by farmers, such as unpredictable light and temperature, the presence of unknown microbes and animals in the soil, and competing weeds. Arthropod interactions can be beneficial or detrimental to plants. We know beneficial insects are economically important both as allies in the biocontrol of pests or vectors and as pollinators. Alternatively, arthropods in rearing facilities can lead to serious occupational health hazards; allergic sensitivity reactions to both allergens produced by insects as well as microbial pathogen containments produced by insect diets and insect frass. This course will cover the basics of biotechnology including traditional and evolving techniques. The field trials section will review APHIS Biotechnology Regulatory Service (BRS) permitting and other documentation along with distances and other field protocols. Insect handling will cover permitting, rearing, containment, proper disposal as well as ways to manage sensitivities and allergens. The course will offer a variety of scenarios and interactive exercises that demonstrate the range of genetically modified, other risks, and hazards routinely encountered in the field and insectary. The course employs “real world” examples to improve understanding of greenhouse and field operations.
Objectives:
- Review biotechnology techniques used in plant research
- Summarize field trial permits, distances, and best practices
- Identify how to contain allergens and avoid sensitivity in arthropod rearing and research
Suggested Background: Fundamentals of Biosafety
Target Audience: All Biosafety Professionals, Laboratory Workers
COURSE FACULTY
Janet Griffiths is the lab manager for the Insect and Plant Propagation Team at BASF. She has worked in this role for the last 10 years. Janet has 17 years’ experience in insect and plant rearing, with 15 of those years in lab management, mostly in multi species labs. Janet has worked with over 40 species of arthropods through the years. Prior to working at BASF, Janet spent 4 years managing insect rearing, plant propagation, and research involving plant/insect interaction at the Soil Arthropod Ecology Lab in the entomology department at North Carolina State University (NCSU). Before NCSU, Janet worked for North Carolina Department of Agriculture (NCDA) in Plant Protection where she supervised the lab that massed reared a predator beetle for release as a management tool for an invasive species. She also worked for NCDA Agronomic Division, working within a chemistry lab processing soil samples for farmers and local residents of NC.
Anita has 10 years of experience in the fields of Occupational Safety, Biological Safety and Laboratory Safety. She has worked at BASF for 35 years and is currently the North America Biosafety Manager. Prior to joining BASF, Anita worked at North Carolina State University in Raleigh, NC. She received a degree in Botany from NCSU in 1983.Anita currently oversees the North American Biological Safety Programs. She works with site biosafety representatives to oversee these areas. She participates and several global biosafety teams at BASF.
Deborah Howard is the Expert, Global Environment, Health and Safety Biological Materials Managerfor BASF where she has oversight of greenhouses, laboratories, inoculant and fermentation sites. She has been the Biosafety Manager at BASF (Bayer buyout in 2018) since May 2014. Deborah has extensive experience with Select Agent regulations, exporting, greenhouse, arthropods, genetically modified plants and animals. She has over 30 years of experience in health and safety and knowledge of regulations including NIH, OSHA, EPA, APHIS, and USDA. Previously, she was the Biosafety Manager at UNC Chapel Hill.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 8:00 AM – 5:00 PM
11. Strategies for Designing and Implementing a Culture of Safety
As biosafety professionals, we all desire to foster a culture of safety and responsible conduct at our institutions. We often have a clear vision of how this culture should look and feel, but how do you move from the current organizational culture to one you desire? In this course, we will define organizational culture; understand how culture forms; and identify artifacts, espoused values, and shared beliefs that can be used to describe an organization’s culture. Participants will use these definitions to identify attributes of their own organization’s culture that support or block a culture of safety and responsibility. Unfortunately, most change efforts in organizations fail. Changing existing cultures is difficult and can take many years. However, several change management models can be employed to develop a roadmap for effecting change. Participants in this class will learn the ADKAR, Lewin, and Kotter change management models and how they can be applied. Participants will apply these models to case studies of organizational change to understand how they can be leveraged in their own organizations.
Objectives:
- Describe what organizational culture is, how to identify and define it, and how it forms
- Identify attributes of your organization’s culture that block or enable safety programs
- Apply change management models such as ADKAR, Lewin, and Kotter models to effect organizational change
Suggested Background: None
Target Audience: All Safety Professionals, Experienced Biosafety Professionals
COURSE FACULTY
Meghan Seltzer is a Lead Technical Assessor with The MITRE Corporation. She earned a bachelor’s degree in Biochemistry and Molecular Biology from the Pennsylvania State University, a doctorate in Cellular and Molecular Medicine from Johns Hopkins University School of Medicine, and a master’s degree in Management, Strategy, and Leadership from Michigan State University. Meghan is a Registered Biosafety Professional and began her biosafety career as a fellow in the National Biosafety and Biocontainment Training Program. After completing her fellowship, she worked at HHMI’s Janelia Research Campus as a manager in the Safety, Health, and Security department. During her tenure at HHMI, she was responsible for biosafety and occupational health programs as well as various research compliance efforts including IACUC, CLIA, dangerous goods shipping, import/export compliance, IRB, and IBC. Meghan is active in ABSA and ChABSA where she has served on numerous committees and council for both organizations.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 8:00 AM – 5:00 PM
12. Advanced BSL-3 Facility Operations
This advanced course is a follow-up to the BSL-3 Facility Operations and Management course and will focus on detailed aspects of biocontainment operations of BSL-3, ABSL-3, and enhanced BSL-3 laboratories. It will cover developing risk assessments for biocontainment facilities; facility operations and maintenance SOPs; maintenance personnel training requirements; solid and liquid waste decontamination equipment, procedures, validations and cycle developments; area decontamination methodologies, procedures, and validations; filtration systems and their validation and testing process; ventilation control methodologies and ventilation equipment configuration; facility testing during normal and failure conditions of the ventilation system; test documentation and record-keeping.
Objectives:
- Explain the facility verification process in detail, including recommended test methodologies
- Identify methodologies for decontamination of areas, equipment, filters, and waste
- Restate the training requirements for facility personnel accessing the biocontainment areas and describe the elements needed for the development of biocontainment facility risk assessments
Suggested Background: Fundamentals of Biosafety, Biosafety Level 3-Design and Operations, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, Experienced Biosafety Professionals
COURSE FACULTY
Miguel A. Grimaldo, DSc., MEng., is an Assistant Professor for the Department of Pathology and the Director of Institutional Biocontainment Resources at the University of Texas Medical Branch (UTMB) in Galveston, Texas. He is also the Director of the Biocontainment Engineering Division for the Galveston National Laboratory. His responsibilities include reviewing all design, construction, commissioning, and operation of UTMB’s containment laboratories. He also ensures regulatory compliance and conducts ongoing evaluation and recertification on all critical containment features, equipment, and operations for Biosafety Level 3 (BSL-3), Animal Biosafety Level 3 (ABSL3), and Biosafety Level 4 (BSL4) laboratory facilities at UTMB. He also is a member of the UTMB Institutional Biosafety Committee. Dr. Grimaldo obtained two Bachelor of Science degrees in the fields of Agricultural Engineering and Agricultural Economics from Texas A&M University (USA), his Master of Engineering in Engineering Management from the University of Louisville (USA), and his Doctorate in Applied Biochemistry from the Federal University of Vicosa, Minas Gerais (Brazil). Before coming to UTMB in 2005, he worked for 13 years for the US Department of Agriculture (USDA) at the US Embassy in Panama, where he was involved with USDA’s Foot and Mouth Disease Prevention Program as well as the Screwworm Eradication Program. Dr. Grimaldo has served as Committee Member for the development of the ANSI Z9.14-2014 Standard – Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities as well as for the 2016 Edition of the National Institute of Health (NIH) – Design Requirements Manual (DRM) for Biomedical Laboratories and Animal Research Facilities. He routinely serves as Biorisk and Biocontainment Advisor for containment laboratories nationally and internationally on design, construction and operations.
John has managed the day-to-day facility operations of high-containment research laboratories since 1995. This is backed by almost 14 years’ additional experience in scientific research. He currently works as Senior MEP Manager, Gilbane Building Company, Columbus, OH. He previously served as Director, Biocontainment Operations, Biocontainment Facility Engineer, Biosecurity Research Institute, Kansas State University. From January 2011 to October 2016, he managed the start-up and operations of The Pennsylvania State University’s (PSU) Pell Laboratory for Advanced Biological Research. Previously, at the Battelle Biomedical Research Center, he started up an ABSL-3, coordinated and oversaw facility maintenance and worked with research staff members and numerous contractors to schedule and carry out maintenance activities safely and efficiently. John’s expertise includes the design, construction, commissioning, engineering, biorisk management and operation of biocontainment facilities, along with the unique ability to understand researcher needs and equip the facility to accommodate them. At Battelle, he served as Chairman of an Environment, Safety, Health, and Surety Committee for 9 years, served on PSU’s Institutional Biosafety Committee and Process Safety Management Focus Group during his time there, and he has been an American Biological Safety Association (ABSA) Registered Biosafety Professional (RBP) since 2011. John has also been an instructor or lecturer on research building operations for ABSA and the Eagleson Institute. He served as one of ABSA’s representatives to the NIH Design Requirements Manual revision committee, as a leader of the ABSA task team supporting ABSA’s involvement in the American National Standards Institute (ANSI) committee to revise the national standard for the verification of BSL-3 facility performance (ANSI Z9.14-2020). John also participated with the non-government review team to provide a revised version of Biosafety in Microbiological and Biomedical Laboratories (BMBL) Appendix D – Agriculture Pathogen Biosafety, for the 6th edition of the BMBL. Most recently, he has been appointed to serve on the ABSA Credentialing Evaluation Board (CEB).
Paul Jennette holds Bachelor’s and Master’s Degrees in Environmental Engineering from Cornell and the University of Massachusetts, respectively, and is both a Registered Professional Engineer and a Certified Biological Safety Professional. Since 1999, he has held the position of Biosafety Engineer at the Cornell College of Veterinary Medicine and has also been the Director of Biocontainment Operations there since 2013. Paul’s responsibilities include:•design, verification, operation, decontamination, and program management related to Cornell’s BSL-3, ACL-3, and ABSL-3 facilities, which include both research & diagnostic laboratories as well as a BSL-3 large animal necropsy; training all Cornell BSL-3 scientific and support staff and providing direct, in-containment support for BSL-3 diagnostic operations; directing the operations of Cornell’s medical and pathological waste treatment facility, which includes a 5,000-lb/batch carcass digester; serving on Cornell’s Institutional Biosafety Committee and directing the Cornell Vet College Rabies Risk Management Program. Paul serves on biosecurity teams for Select Agent Labs at the Cornell Vet College and provides technical support for the College’s effluent decontamination systems. He served as the American Biological Safety Association’s representative on the ANSI committee to develop a national standard for the verification of BSL-3 facility performance, is a reviewer and lead author of a technical column for the Applied Biosafety journal, and is a member of ABSA’s Professional Development Team. He is a former co-chair of ABSA’s Principles & Practices of Biosafety class as well as a regular instructor for BSL-3 courses offered by the Eagleson Institute and ABSA. In addition to his position at Cornell, Paul provides biocontainment operations consulting services to a variety of academic, governmental, and pharmaceutical clients.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 8:00 AM – 12:00 PM
13. A Practical Guide to Effluent Decontamination System (EDS) Selection, Maintenance, and Operations
Involvement and knowledge are important for the biosafety professional in the selection, maintenance, and operation of their institution’s effluent decontamination system. There are numerous types and sizes of effluent decontamination systems ranging from small under-the-counter sink units to large thermal systems capable of treating more than 100,000 gallons per day. The first major topic covered is whether a facility requires an EDS for operations. This need can be based on either regulatory or institutional requirements. Discussions will be held on how an institution’s research profile can tailor the EDS selection process to find the best system fit; the types of systems—chemical and thermal either in batch-based or continuous flow design and the pros/cons of each. Once an EDS is selected, participants will be instructed on the aspects of system design and installation that can affect safety and operations within a laboratory facility. Another key topic is the maintenance of the EDS. Maintenance requirements can vary widely between the type of EDS and whether it is handled by in-house staff or external contractors. Benefits and downsides to each approach will be described along with potential effects on laboratory operations in the event of a disruption in operations. Finally, participants will have a discussion based on a series of case studies related to EDS operational issues in the real-world setting. While there are certain aspects that will involve engineering discussions, this course is intended to be an overview for biosafety professionals to understand the right questions to ask during the selection, design, installation, maintenance, and operations of an effluent decontamination system.
Objectives:
- Describe the types of effluent decontamination systems and what biosafety professionals need to know during installation
- Summarize key terms for maintaining an effluent decontamination system during active laboratory operations
- Identify lessons learned from case studies and apply them to their own facility, if applicable
Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
COURSE FACULTY
Dave is currently a Safety and Occupational Health Manager for the Center of Veterinary Medicine at the FDA. Prior to his current position, he served as the Program Director of the National Biosafety and Biocontainment Training Program at the National Institutes of Health. Before that, he served as the Biological Safety Officer at the United States Army Medical Research Institute of Infectious Diseases (2012-2021). Prior to working at USAMRIID, he was a fellow in the National Biosafety and Biocontainment Training Program. Proceeding the fellowship, he graduated with his B.S. in Biochemistry from Virginia Tech and his Ph.D. in Toxicology from UNC-Chapel Hill. Dave has been an ABSA member since 2010 and has previously served as the Chair of the Pre-Conference Course Committee as well as Chair of the Training Tools and Resources Committee in addition to being a member of the Standards Committee, Professional Development Team and Select Agent Community Advisory Committee for ABSA. He has recently been named Co-Chair of the ABSA Ambassadors Committee. Locally, Dave has previously been a Councilor for the Chesapeake Area Biosafety Association as well has chair of the Scientific Program Committee for its annual symposium. Dave is also currently a member of the Exam Development Committee for the CBSP exam and previously served as Chair of the DoD Biosafety and Scientific Review Panel. Dave is certified as a biosafety professional through both ASM and ABSA.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 8:00 AM – 12:00 PM
14. Intersection of Biological Safety and the Clinical Environment: Practical Application of Biosafety Principles and Practices for the Healthcare Setting
Clinical environments are subject to oversight by several entities, including the Joint Commission (JCAHO), College of American Pathologists (CAP), and the Clinical Laboratory Improvement Amendments (CLIA) for accreditation of their spaces, personnel, and work practices. These accreditation bodies prioritize safety as one of the major areas of oversight during their site visits. At large academic teaching hospitals, in ensuring compliance with accreditation standards, functions of the Biological Safety Office often intersect with other safety groups, such as Infection Prevention and Control, Fire and Life Safety, Engineering and Operations, Clinical Engineering, and Emergency Response. Additionally, clinical environments are faced with their own set of challenges, from the fast-paced, dynamic response to patients to the unknown biological agent that may present itself in diagnostic samples to the uniquely hazardous procedures such as autopsies, intubations, HAZMAT, etc. These challenges require a holistic, risk assessment-based, coordinated response, and increasingly the biosafety professional is called upon to play a key role in the clinical environment. This course will provide an overview of the multiple types of clinical environments: inpatient units, primary and specialty care clinics, and clinical laboratories, including BSL-3, and their defining characteristics. The different risks associated with these environments will be explained and strategies to effectively work with other safety groups to mitigate the risks will be shared from real-life experiences. Participants will engage in interactive, group case study exercises and practice performing risk assessments for specific issues faced in the clinical environment. Course participants will benefit from understanding the synergistic relationships among these various safety groups and will be equipped to lead clinical entities in achieving a state of readiness.
Objectives:
- Describe the clinical environment and accrediting bodies, and how it differs from a traditional research environment
- Develop a working knowledge of how best to work with the various safety groups within the clinical environment
- Perform a risk assessment to determine the best course of action in the clinical environment for biosafety issues based on case studies
Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Safety Professionals, All Biosafety Professionals
COURSE FACULTY
Sarah Mikati is the Environment of Care Performance Specialist in the Biological Safety Division of the Occupational and Environmental Safety Office at Duke University Hospital System. Sarah administers the Environment of Care program, which includes evaluating all clinical areas twice a year. She also oversees the Tuberculosis Program and collaborates with Infection Prevention and Control closely on clinical biosafety concerns. Sarah’s background is in clinical nursing on the cardiothoracic unit, followed by clinical research on new therapeutic devices before she joined the Biological Safety Division. She finds that her clinical background grants her a unique perspective to biosafety and recognizing the complexities of the clinical environment. Her interests include biosafety in the clinical setting, creating best practices for clinical environments, and training other professionals in biological risk assessment. Sarah received her Bachelors of Nursing from the University of North Carolina at Charlotte and her Masters of Science in Nursing from Duke University.
Dr. Andrea Vogel is currently a Safety and Health Specialist in the Biological Safety Division of the Occupational and Environmental Safety Office at Duke University Health Systems. She is also an Alternate Responsible Official for the Select Agent Program. The Biological Safety Division oversees programs implemented for mitigating biological hazards at Duke University, Duke University Hospital and Clinics. Programs she oversees include the Bloodborne Pathogens Exposure Control Program, Tuberculosis Control Program, and the BSL-3 Laboratory Program. Dr. Vogel has been a member of ABSA International since 2021 and is an active member of the Journal Board, Finance Committee, Awards Committee, and Pre-Conference Course Committee. Her interests include biosafety/biosecurity program management, risk assessment of emerging infectious diseases and technologies, and application of technology to enhance understanding in training programs. Dr. Vogel received her PhD in Genetics from North Carolina State University, and was a NIH NBBTP Fellow. She has authored several papers ranging from validation of hydrogen peroxide vapor to facilitate re-use of N95s to animal behavior and group coordination.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 1:00 PM – 5:00 PM
15. Facility Operations and Maintenance with a Biosafety Twist
Do laboratorians realize that their safety is in the hands of their facility operations and maintenance (O&M) staff? Does the O&M staff understand the importance of their job and responsibilities? The O&M staff at a facility is an integral component to keeping a research facility functioning at its set parameters and helping to ensure overall biosafety and biosecurity. Often laboratory facilities hire individuals to perform maintenance tasks in or in an environment that they have not worked in previously, i.e., a laboratory, animal containment, or even decontamination systems supporting containment work. While general safety, such as OSHA requirements, are addressed through their general environmental health and safety programs, there is often an apparent disconnect between biosafety practices and training. This course will discuss the role that biosafety has in providing O&M staff with the appropriate training and ongoing interactions and communication in the areas of: specialized equipment; infrastructure; hazard communication in relation to science; biological safety; personal protective equipment; risk assessments; and ongoing training.
Objectives:
- Identify biosafety and biorisk training tools or methods that can be used in providing training to Operations and Maintenance personnel
- Describe ways that biosafety and biorisk professionals can learn the specific systems that support their facilities so they can communicate effectively with Operations and Maintenance personnel
- Apply methods of risk assessment tools to Operations and Maintenance incident response planning
Suggested Background: None
Target Audience: All Safety Professionals, Facilities Operations and Maintenance Personnel
COURSE FACULTY
Dr. Gamble is the Associate Director, Biorisk Management Programs within Science & Technology in the Life Sciences practice at Merrick. Rachel has 15+ years of experience directing and managing safety programs for two biomedical research institutions with focused experience in biological safety and select agent regulations. She previously served as the Director of the Office for Environmental Safety as well as the director for the high containment/select agent research facility at Baylor College of Medicine. Dr. Gamble has recently worked on the stand-up of the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS, on behalf of the U.S. Department of Homeland Security and the U.S. Department of Agriculture in addition to various projects for government and academic institutions both domestic and international. She holds a doctorate in public health, CBSP and RBP certifications, held previous Southern Biosafety Association (SBA) positions (treasurer, vice president, president, and past president), current vice president of SBA, serves as an ad hoc
Mr.Tremblay has over 25 years’ experience in the construction industry with the last 25 years focused on laboratories and containment facilities as a controls and commissioning subject matter expert (SME). His experience with containment (PC4/3/2) laboratories includes designing control systems, start-up and commissioning of facilities for the owner, and developing standard operating procedures (SOPs) for the facility operations team. He often serves as a technical advisor in the controls and fail-safe operation of containment facilities and regularly presents at conferences.Currently he is one of the lead instructors providing operational training for the facility team at the new NBAF Laboratory in Manhattan, KS. This is an on-going multi-year effort that incorporates various training modules such as: Incident Response, Alarm Management, CMMS, Building Automation, Tissue Autoclaves, Effluent Treatment Systems, Breathing Air, Chemical Shower, APR Doors and more.
Mr. Ziegler is a registered professional engineer in the United States and Canada, and has over 25 years of experience with design, construction oversight, and commissioning of HVAC and specialty plumbing systems for BSL-3, BSL-3Ag, and BSL-4 laboratories worldwide. Mr. Ziegler has been a senior design engineer with Merrick and Company for the past 14 years, and with Hemisphere engineering for more than 10 years before that. Mr. Ziegler has been the lead engineer for multiple projects with a special focus in effluent decontamination systems, solid and tissue waste disposal systems, BSL4 chemical shower and breathing air systems, and laboratory ventilation control strategies. Mr. Ziegler has extensive field experience during construction, commissioning, and operation, which allows for real life examination of engineering systems, including constructability as well as long term maintenance analysis. Mr. Ziegler has authored articles as well as presented for such organizations as ABSA, Tradelines, Eagleson, and I2SL. Topics are focused on laboratory engineering systems design and operations.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.
Sunday, October 16, 2022, 1:00 PM – 5:00 PM
16. Clinical Trials and the Role of IBCs in the Oversight of Human Gene Transfer (HGT)
Over the last decade, there has been exponential growth in the pre-clinical and clinical pipelines involving gene therapies, RNA therapies, and genetically-modified cell therapies. While there has been a significant expansion in the number of clinical trials utilizing these therapeutic approaches for the treatment of cancers, rare diseases, and infectious diseases (among others), there has also been increased pressure and responsibility on Institutional Biosafety Committees (IBCs) to expertly navigate these rapid advances in human gene transfer (HGT) technology and safely review such trials, as required, under the NIH Guidelines governing such research. This course will provide a general overview of the current status of human gene transfer research and FDA-approved clinical applications; review common gene delivery platforms; review biosafety risks and considerations unique to the application of gene transfer in the clinical setting; will outline the regulatory environment for clinical research using gene transfer technologies; and an overview of the NIH Guidelines, biosafety oversight of human gene transfer clinical trials, and best practices for local Institutional Biosafety Committees in reviewing HGT trials. A review of the regulatory requirements surrounding the use of gene therapy drugs approved by the FDA in clinical trials and in clinical practice will be discussed as well as participating in case studies and group discussions that will amplify the course’s take-home messages.
Objectives:
- Restate the unique biosafety risks and challenges associated with human gene transfer, and identify best practices for IBCs reviewing HGT trials
- Identify the categories and risk groups of biological agents and vectors commonly used in human gene transfer
- Describe the key regulatory roles of IBCs in the oversight of human gene transfer research
Suggested Background: None
Target Audience: All Biosafety Professionals, Clinical Professionals, IBC Administrators
COURSE FACULTY
Garry has over 17 years of biomedical research experience in university, government, and private research settings. He has a wide range of experience in microbiology, molecular biology, immunology, and has experience serving as the Biological Safety Officer at the University of North Carolina at Chapel Hill and is currently serving as IBC Chair of Clinical Biosafety Services. He holds a master’s degree in clinical microbiology and infectious diseases and a doctorate in infectious diseases. Our focus is to accelerate the trial and remove regulatory burden and uncertainty by having our highly trained experts provide friendly, knowledgeable support during the review process. We understand these therapeutics will change medicine, and our service is to bring the trial to enrollment fruition, quickly and compliantly.
Nick Noriea is a research-trained Biosafety professional from the gulf coast. He holds a BS in Biology, a MS in Computer Science, and a PhD in Microbiology. Prior to entering biosafety, he was a postdoctoral fellow at the National Institutes of Health in the field of Rickettsia pathogenesis. Nick has previously served as biosafety officer in academia and currently serves as one of the IBC Chairs at Clinical Biosafety Services overseeing the administration of hundreds of Institutional Biosafety Committees reviewing human gene transfer research. As part of these responsibilities, Nick provides leadership and support to these committees and coordinates committee findings and recommendations with their respective Institution.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.0 P.A.C.E.® contact hours.