Professional Development Courses
In-Person Courses
Raleigh Convention Center—Raleigh, North Carolina, October 24-26
(in-person courses are in Eastern Standard Time)
Basic Level Courses
For those new to the profession or would like training in a particular topic.
Friday, November 1, 2024, 8:00 AM – 5:00 PM
1. 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 attendees. 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
Audience Level: Basic
COURSE FACULTY
J. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA)
Biosafety Engineer
Director of Biocontainment Operations
Cornell College of Veterinary Medicine
Ithaca, NY
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.
Carrie Smith is a seasoned biosafety professional with over fifteen years of experience spanning academia, government, and the private sector. As a Senior Scientist at Merrick & Company, she specializes in biosafety and laboratory operations planning, helping clients design and transition laboratories through new constructions, renovations, and strategic upgrades. Her expertise also extends to training, biosafety program development, standard operating procedures (SOPs), manuals, decontamination strategies, and other critical biosafety initiatives. Before joining Merrick, Carrie held key roles in biosafety leadership, serving as BSO and ARO at Oklahoma State University, a biosafety specialist and trainer at the University of Wisconsin-Madison, and BSO and ARO at the USGS National Wildlife Health Center. She earned her undergraduate degree in Biology with a concentration in Biotechnology from the University of Delaware and went on to complete her PhD in Genetics at North Carolina State University, where her research encompassed recombinant bacteria, viruses, fungi, plants, and biological toxins. Throughout her career, Carrie has successfully led both small and large biosafety programs, demonstrating expertise in BSL-3/ABSL-3 oversight, atypical animal biocontainment, select agent program management, recombinant technology, plant biosafety, diagnostic laboratory protocols, and the development of online and in-person training. In addition to her professional contributions, she is deeply involved in educational initiatives, serving as an instructor for ABSA’s Principles & Practices of Biosafety Course, teaching the ABSA BSL-3 Operations and Management professional development course, and actively participating in the Preconference Course Committee.
Dee Zimmerman retired from the University of Texas Medical Branch, Environmental Health and Safety. She was the university biosafety officer, director of the health, safety and training core for the University of Texas Medical Branch—Galveston (UTMB) National Laboratory, senior environmental health and safety consultant in the Biological Safety program and served as the university’s select agent program alternate responsible official, IBC member and coordinator. Her duties include working closely with research staff in BSL-2, BSL-3, BSL-4, ABSL-2, 3, and 4 laboratories working closely with research scientists, biocontainment engineers, facility staff and occupational health. Dee was with the University of Texas Medical Branch from 1982 until retiring in 2017. She attended Inter-American University in Puerto Rico and was the lab and safety coordinator for the Marine Ecology Division, Center for Energy and Environmental Research at the University of Puerto Rico. Dee is the 2019 Past President of ABSA International.
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 7.5 P.A.C.E.® contact hours.
Friday, November 1, 2024, 8:00 AM – 5:00 PM
4. Intersection Between Biosafety and Infection Control: An Introduction to Infection Control and Biosafety in Clinical Spaces
This course is meant for the biosafety professional who would like to learn more about application of biosafety principles in the clinical environment and partnering with Infection Control Departments in health systems. This is increasingly important as clinical trials using biological therapeutics, such as human gene transfer (HGT), require safety professionals to develop investigational product handling, preparation, and administration protocols that align with current clinical safety practices and environments. The goals of this course are to introduce different clinical environments, specific biosafety considerations for each space, hospital regulatory requirements that influence safety protocols, and how to collaborate with hospital infection control professionals to operationalize safety protocols in a way that’s meaningful to hospital staff.
Objectives:
- Describe inpatient, procedural and outpatient clinical environments and how this affects implementation of Biosafety Practices
- Restate the similarities and differences between biosafety levels, isolation precautions and standard precautions
- Summarize how NIH and BMBL guidelines relate to hospital regulatory and accreditation requirements when creating protocols for HGT clinical trials
Suggested Background: Principles and Practices of Biosafety® (PPB), Risk Assessment
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
Allison Reeme, PhD, RBP(ABSA), CIC, has over 8 years of experience in infection prevention and hospital epidemiology at an academic medical center consisting of acute care, procedural and outpatient care settings. She has led multiple quality improvement projects, assisted in hospital credentialing preparedness, mitigating outbreaks of multidrug-resistant organisms and designing clinical spaces. Allison has 8 years of experience serving as a Human Gene Therapy expert (HGT) and Biosafety Expert on Institutional Biosafety Committees, supported CAR-T cell manufacturing facilities and assisted with the training and education of clinical staff supporting HGT clinical trials. Allison has also participated in multiple OSHA and NIH compliance programs in both the clinical and laboratory setting. She is certified through the Certification Board of Infection Control and Epidemiology, is a Registered Biosafety Professional through ABSA International and has doctoral degrees in Microbiology, Immunology & Molecular Genetics and Translational Science.
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 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 5:00 PM
5. Facilities Fundamentals for Biosafety Professionals
This course is aimed at strengthening biosafety professionals knowledge of how facility operations support overall biocontainment operations. The first portion of the course will familiarize attendees with the general concepts biosafety-related facility design and their roles in it, along with the fundamentals of HVAC system operation in the context of BSL-2 and BSL-3 facilities. Topics in this portion of the course include: the role of biosafety personnel in biocontainment facility design, renovation, and operations, understanding design drawings and related construction documents, what the relationship is of facility features to biosafety levels, and HVAC components and their function relative to biocontainment. The instructors will lead discussions of more detailed aspects of containment facilities and their operation, including: specific infrastructure, equipment, and systems related to operation of a biocontainment facility; autoclave function, waste management, associated facility infrastructure; room decontamination in relation to facility components; interactions between facilities and containment equipment; security, operations, and biosafety. Through a mixture of presentations from experts in the field and interactive exercises, attendees will reinforce their knowledge of facility system function and their roles in facility design, construction, and operation. The target audience for the course is biosafety professionals who come with backgrounds other than facilities, and it is open to both newcomers and seasoned veterans in the field.
Objectives:
- Restate the roles of biosafety professionals in facility design and operation
- Explain practical approaches for reviewing design documents.
- Describe the function of discrete facility infrastructure, equipment, and systems related to biocontainment facility operations
Suggested Background: BSL-3 Operations and Management, Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB)
Target Audience: All Biosafety Professionals, All Safety Professionals
Audience Level: Basic
COURSE FACULTY
J. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA)
Biosafety Engineer
Director of Biocontainment Operations
Cornell College of Veterinary Medicine
Ithaca, NY
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.
Rachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA)
Pond & Company
Peachtree Corners, GA
Rachel is the Associate Director of Biorisk Management Programs within the Life Sciences practice at Merrick. She holds a Doctor of Public Health in Occupational and Environmental Health Sciences (concentration in epidemiology and disease control) from The University of Texas School of Public Health. In addition to her degrees, she has held the CBSP credential since 2011, and has over 18 years of experience in the field. Previously, Rachel served as the Director of the Office for Environmental Safety and the high containment/select agent research facility at Baylor College of Medicine (BCM). She was also an assistant professor in the Molecular Virology and Microbiology department. Since her departure from BCM and joining Merrick, she has diversified and grown her knowledge and experience base by working on projects for the USDA, Department of Homeland Security, Public Health Ontario, Centro Medico NAVAL (CEMENAV), NASA, Biosecurity Engagement Programs in the East Asia Pacific Region, MD Anderson Cancer Center, NIH, Labs Canada, and various colleges and universities across the United States.
Stephen Helgren is a Senior Architect and Laboratory Planner for Merrick & Company, with over 24 years of diversified experience in complex life science facilities and extensive expertise in laboratory programming, planning, design, and construction. He has experience with BSL-3 facilities for private companies, public universities, the USDA, and Canadian clients.
Fahim Manzur is a Senior Commissioning Specialist within the Life Sciences Commissioning Group at Merrick and Company. Fahim has 16+ years of experience in facility engineering, facility/laboratory operations and maintenance, laboratory/equipment commissioning and decommissioning, biological safety, and select agent regulatory compliance at high-containment biological laboratories. Notable work includes projects for USDA, DHS, and Mexico (University and Federal) biocontainment facilities. Prior to joining Merrick, Fahim worked as a consultant and operations & maintenance biological compliance engineering supervisor for the Plum Island Animal Disease Center (PIADC) for over 13 years. While at PIADC, Fahim oversaw facilities upgrades, supported biocontainment construction and commissioning projects, led decontamination and decommissioning efforts for containment spaces, and managed the effluent decontamination system building. Fahim is currently primarily providing support for PIADC terminal decontamination and decommissioning efforts at PIADC with Merrick. He holds a Masters in Biomedical Engineering from the University of Connecticut and is a Registered Biosafety Professional (RBP) through ABSA. Fahim has been a member of ABSA since 2009 and has participated in multiple conferences through poster sessions and platform presentations over the years.
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 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 5:00 PM
8. 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, 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. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small 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 attendees during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to attendees’ individual programs and providing a platform to capitalize on attendees’ collective experience.
Objectives:
- Identify strategies for efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements, including anticipating areas of emphasis in future inspections and/or future regulatory changes
- Indentify strategies for preparing for and responding to regulatory inspections, including strategies to efficiently implement necessary changes
- Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns
- Summarize inactivation requirements and identify successful strategies for compliance
Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
Audience Level: Intermediate
COURSE FACULTY
Amy Vogler, PhD, RBP(ABSA)
Associate Director – Pathogen and Microbiome Institute
Northern Arizona University
Flagstaff, AZ
Amy Vogler 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 45 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.
Shelley Jones, MS, RBP(ABSA)
Director of Biological Safety | Responsible Offical
Northern Arizona University
Flagstaff, AZ
Shelley Jones 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 19 years.
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 7.5 P.A.C.E.® contact hours.
Intermediate Level Courses
For those with basic knowledge or would like to learn more.
Friday, November 1, 2024, 8:00 AM – 5:00 PM
2. 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. 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 short interactive 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 U.S. 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 attendees for IATA/DOT certification.
Objectives:
- Review and restate shipping regulations for both air and ground with a particular focus on 49 CFR US DOT and IATA air regulations
- Conduct a 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, Laboratory Workers
Audience Level: Basic
COURSE FACULTY
Eric Cook, MPH
Senior Member – Technical Staff
Sandia National Laboratories
Albuquerque, NM
Eric Cook is a Senior Member of the Technical Staff in the International Biological and Chemical Threat Reduction Program at Sandia National Laboratories where his work focuses on promoting global laboratory biorisk management. He serves as one of the program’s lead trainers. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he managed the Biosafety Program and Institutional Biosafety Committee. Prior to working at Dartmouth, Eric was an Assistant Biosafety Officer at the Massachusetts Institute of Technology for six years. 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 where he worked in a recombinant DNA lab for two years assisting with work in phylogenetics. He is certified by the National Registry of Certified Microbiologists as a Specialist Microbiologist in Biological Safety Microbiology and previously by ABSA International as a Certified Biological Safety Professional. Eric has particular expertise in dangerous goods and infectious substance shipping. He worked for three years at Saf-T-Pak, Inc. developing training programs and packaging for shipping infectious substances.
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 7.5 P.A.C.E.® contact hours.
Friday, November 1, 2024, 8:00 AM – 5:00 PM
3. 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, attendees 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: None
Target Audience: New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
COURSE FACULTY
CONTACT HOURS
Dr. David Harbourt is a Safety and Occupational Health Manager for the Center of Veterinary Medicine at the U.S. Food and Drug Administration (FDA). Prior to his current position, he served as the Program Director of the National Biosafety and Biocontainment Training Program (NBBTP) at the National Institutes of Health. Before that, he served in a variety of roles at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) including Biosafety Officer, Chief of the Biosafety Division and Deputy Director of the USMARIID Transition Office (2012-2021). Prior to working at USAMRIID, he was a fellow in the NBBTP. Preceding the fellowship, he graduated with his B.S. in Biochemistry from Virginia Tech (’05) and his Ph.D. in Toxicology from UNC-Chapel Hill (’09).
Dr. Harbourt has been an active member of ABSA International since 2010; has previously served as the Chair of the Preconference Course Committee and Chair of the Training Tools and Resources Committee; and currently serves as a member of the Exam Development Board for the CBSP Exam. He has also been a member of the Standards Committee, Professional Development Team, and BSAT Community Advocate Committee for ABSA. He has recently been named Co-Chair of the ABSA Ambassadors Committee. Locally within the Chesapeake Area Biosafety Association, Dave has been a Councilor, Chair of the Scientific Program Committee for its annual symposium, and Chair of the Pre-Symposium Committee. Previously, Dr. Harbourt served as Chair of the DoD Biosafety and Scientific Review Panel.
Dr. Harbourt has published several articles on topics relevant to biosafety including bacteriology, virology, agent inactivation, effluent decontamination systems, and risk assessment. He has also taught courses both at ABSA and at local universities on biosafety, risk assessment, emergency management, and effluent decontamination systems. Dave is a Registered Biosafety Professional and Certified Biological Safety Professional through ABSA International and a Specialist Microbiologist (NRCM) through the American Society of Microbiology.
Rachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA)
Pond & Company
Peachtree Corners, GA
Rachel is the Associate Director of Biorisk Management Programs within the Life Sciences practice at Merrick. She holds a Doctor of Public Health in Occupational and Environmental Health Sciences (concentration in epidemiology and disease control) from The University of Texas School of Public Health. In addition to her degrees, she has held the CBSP credential since 2011, and has over 18 years of experience in the field. Previously, Rachel served as the Director of the Office for Environmental Safety and the high containment/select agent research facility at Baylor College of Medicine (BCM). She was also an assistant professor in the Molecular Virology and Microbiology department. Since her departure from BCM and joining Merrick, she has diversified and grown her knowledge and experience base by working on projects for the USDA, Department of Homeland Security, Public Health Ontario, Centro Medico NAVAL (CEMENAV), NASA, Biosecurity Engagement Programs in the East Asia Pacific Region, MD Anderson Cancer Center, NIH, Labs Canada, and various colleges and universities across the United States.
Katie George lives in Missoula, Montana and is currently an Associate Partner and Human Gene Therapy Biosafety Officer for Clinical Biosafety Services (Chesterfield, MO) working with clinics, universities, and hospitals in the United States and Canada prepare for IBC review of Human Gene Therapy (HGT) clinical trials.
Katie holds a BS in Biology from the University of Iowa, a PhD in Biochemistry from Northwestern University, and an MPA from Purdue University. After obtaining her PhD, she was a post-doctoral fellow at the National Institutes of Health researching mycobacterial pathogenesis. After her post-doctoral position, she served as faculty at the University of Montana teaching and leading a research team studying organophosphate pesticide toxicology. Later, she taught medical students at the Medical University of the Americas (Nevis, West Indies). During her career, Katie has worked as a toxicology consultant for the State of Montana Public Defenders and the State of Montana Department of Public Health and Human Services.
Katie has been an ABSA member since 2020 and a Registered Biosafety Professional since 2021. She currently serves on the Distance Learning Committee for ABSA International.
Berenice Arriaga works at The University of Texas at El Paso, as the Assistant Director and Biosafety Officer in the office of Environmental Health and Safety. She received her bachelor’s in science (BS) in Microbiology and a master’s in business administration (MBA) with a Nursing concentration from The University of Texas at El Paso. Being a native from El Paso, TX, she started her career pretty early on volunteering in a Chagas Disease laboratory at UTEP. She later became the Laboratory Coordinator of the Howard Hughes Medical Institute (HHMI) grant at UTEP. Here she oversaw the Prokaryotic Molecular Genetics (PMG) and Molecular Cell Biology (MCB) courses. Her biosafety career started in 2010 when she became the Biocontainment Safety Manager for the Biosafety Level 3 laboratories at UTEP. In this position, she was promoted to Biosafety Officer and obtained her Specialist Microbiology (SM) certification from the National Registry of Certified Microbiologist (NRCM). She is credentialed as well as a Certified Biological Safety Professional (CBSP) through ABSA and an Associate Professional through the Board of Certified Safety Professionals.
She currently oversees the Biosafety, Food Safety, Occupational Health, Indoor Air Quality, Ergonomics, Laboratory Safety Inspection and Workers Compensation Programs at UTEP. As an active member of ABSA, she serves currently in the Distant Learning Committee (DLC) and is currently serving as a Board member in the Southern Biosafety Association (SBA). This year 2024 she hosted at UTEP the first International Symposium in joint collaboration with SBA, AMEXBIO and ABSA. This was the first biosafety symposium between the USA and Mexico both hosted in person/virtual and in English/Spanish.
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 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 12:00 PM
10. Introduction to Biosafety
This course is designed for individuals new to the profession, EHS professionals needing an understanding of biosafety, and for those interested in a refresher on the fundamental principles and practices of biosafety. Participants will gain a solid foundation in biosafety concepts, enabling them to understand and mitigate risks associated with biological materials in various laboratory settings. Class content and discussion include regulatory standards and guidelines, hazard identification, risk assessment and mitigation. Mitigations discussed will include biosafety levels and facility design, proper choice and use of personal protective equipment, waste management, decontamination and sterilization, and more.
Objectives:
- Identify the breadth of duties that may be central or peripheral to a biosafety professional
- Restate the major sources of regulatory and guidance materials available to them
- Describe the roles others within the institution play in supporting biosafety
Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
COURSE FACULTY
Scott Alderman has more than 28 years of biosafety experience and is currently the Director of Safety and RBL Operations for the Human Vaccine Institute at Duke University. He provides oversight of a comprehensive safety program for the Institute, which includes the Regional Biocontainment Laboratory, a BSL-3/ABSL-3 facility that is currently registered with the CDC Select Agent Program. Scott is a voting member of Duke’s Institutional Biosafety Committee and is the Program Manager for the Duke Infectious Disease Response Training (DIDRT) consortium, a federally funded program through the National Institutes of Environmental Health Sciences. Over the past three years, more than 2000 healthcare and clinical laboratory workers have received tailored training through the DIDRT program on safely performing their assigned work duties during infectious disease outbreaks. Scott has a Bachelor of Science in biology from Radford University and a Master of Science in environmental sciences and engineering from the University of North Carolina at Chapel Hill. He has been an active member of the American Biological Safety Association (ABSA) since 1996, including past service as a Councilor for the Association. Scott is a member and Past-President of the Carolinas Biological Safety Association, an affiliate of 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 3.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 12:00 PM
11. Integrating AI into Synthetic Biology: A Biosecurity Risk Assessment Course
This intensive half-day course is designed for biorisk management professionals who are at the forefront of integrating Artificial Intelligence (AI) into synthetic biology. With AI rapidly transforming scientific research and applications, its adoption presents unique biosecurity challenges. This course provides an in-depth look into the specialized biosecurity risk assessment process tailored for AI applications in synthetic biology, combining theoretical foundations with practical, hands-on exercises and interactive case studies. Some of the topics to be covered include: an overview of AI technologies and their applications in synthetic biology; fundamentals of biosecurity risk assessment for AI; discuss the concepts of vulnerability, threat, risk, consequence, and mitigation; develop a dynamic risk management plan and strategies for continuous monitoring and updating of risk assessments to address the evolving nature of AI technologies and synthetic biology applications. Attendees will also discuss the challenges of maintaining an adaptable and proactive risk management stance in a rapidly advancing scientific field.
Objectives:
- Explain at a basic level the AI integration in synthetic biology research
- Identify associated biosecurity risks
- Apply a structured approach to assess these risks using newly developed tools and methodologies
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic
COURSE FACULTY
Dr. Leyma P. De Haro received a BS in Biochemistry from California State University, Los Angeles, and holds a PhD in Biomedical Sciences from the University of New Mexico. She is a Registered Biosafety Professional (RBP) by ABSA International. She completed two postdoctoral fellowships, including one at Los Alamos National Laboratory. Dr. De Haro worked at Sandia National Laboratory, in the internationally renowned Global Chemical and Biological Security Team, where she specialized in Biosafety and Biosecurity on a global scale. She is currently a senior scientist at Merrick & Co. Dr. De Haro has over 15 years post PhD experience as a scientist, helping laboratories and organizations enhance their biosafety and biosecurity practices. Her background in innovative scientific research enables her to understand the unique safety challenges laboratories and organizations face in today’s rapidly evolving world of life sciences. With a keen focus on fostering a culture of responsibility and safety, Dr. De Haro is committed to promoting best practices in biosafety and biosecurity worldwide, supporting the life sciences community in pursuing groundbreaking discoveries and innovations. Relevant recent publications in AI: Book: 1. Biosecurity in the Age of Synthetic Biology. CRC Press (September 2024). Book Chapter: 1. Security Risk Assessment of Research Self-Driving Laboratories (SDLs). CRC Press, accepted. Published Primary Research Articles: 1. De Haro L.P. Using Embodied AI Agents to Automate Biorisk Management Tasks in High-Containment Laboratories. Applied Biosafety (2025-in press). 2. De Haro L.P. Biosecurity Risk Assessment for the Use of Artificial Intelligence in Synthetic Biology. Applied Biosafety (2024),(29)2. DOI: 10.1089/apb.2023.0031 (impact factor: 1.5, citations: 1).
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 3.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 1:00 PM – 5:00 PM
13. Field Research Safety for Biosafety Professionals
Biosafety professionals are often tasked with reviewing field research protocols, but many biosafety professionals have never received training in field research safety. In this course, attendees will review hazards inherent to fieldwork, lessons learned from past incidents, and assess risk for a variety of field projects. The attendees will discuss safe work practices in the field and exposure control approaches for zoonotic, vector-borne, soil-borne, and water-borne diseases. The course will also assist attendees to identify potential gaps in institutional and regulatory oversight and steps to improve a culture of safety and preparedness in the field.
Objectives:
- Review common environmental hazards; zoonotic, vector-borne, soil-borne, and water-borne diseases relevant to outdoor or remote fieldwork
- Evaluate risk tolerance as it relates to protocol and research review
- Assess risk for a variety of field projects including wildlife research, community health studies, excavating soil, plant surveys, etc.
- Identify reasonable controls and expectations
- Describe the compliance drivers, model field safety programs, written field safety plan templates; as well as best practices, technical references and potential actions to improve culture of safety and preparedness in the field
Suggested Background: None
Target Audience: All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
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 3.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
14. Medical Emergencies in the Laboratory – Are you prepared?
Biological Sciences form the foundation of medical research and healthcare including: biochemistry, molecular, cellular, developmental biology, microbiology, plant biology/pathology and public health. Biosafety professionals regularly train staff to handle spills, exposure to chemicals, weather related events, power outages, and biosecurity, but what about medical emergencies? Your organization may have emergency response procedures, but are the individuals in the lab, field, or even visitors prepared to handle first aid in situations involving biologicals? Personnel should be able to recognize and react to medical emergencies they may encounter at your institution involving biologicals. Early recognition of potential medical emergencies can reduce long-term or deadly consequences and legal challenges. Medical emergencies may involve only one individual or it can be a large-scale emergency. Prepare your personnel to respond appropriately in order to avoid worsening the situation. Discover ways to improve communication and cooperation with internal emergency response teams and local emergency responders (911 operators, fire, EMS, law enforcement) when biologicals are involved. Consider the impact when First Responders arrive on scene and see a BSL-2 or BSL-3 sign. If an ambulance is required, is the patient ready to transport? Although you cannot predict every emergency, preparing your personnel to think through a response by preplanning for an event and the steps to recovery is necessary to simplify an emergency response. This class will offer guidance and assistance in preparing for emergencies.
Objectives:
- Establish relationships with local emergency response
- Summarize the right response in a medical emergency
- Communicate the decontamination procedures to employees and emergency responders
Suggested Background: Basic first aid
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
COURSE FACULTY
Deborah Howard, MPH, CBSP(ABSA)
Global Environment, Health, and Safety Biological Materials Manager
BASF
Durham, NC
Deborah Howard is the Expert, Global Environment, Health & Safety Biological Materials Manager for BASF where she has oversight of greenhouses, laboratories, inoculant, & fermentation sites. She has been the Biosafety Manager at BASF since May 2014. Deborah has extensive experience with IBC’s, IACUC, Select Agent regulations, exporting, greenhouse, arthropods, genetically modified plants, & animals. She has over 30 years of experience in health and safety & knowledge of regulations including NIH, OSHA, EPA, APHIS, & USDA. Previously, she was the Biosafety Manager at UNC Chapel Hill where she was the IBC Administrator for 6 years.
Anita Harrell 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.
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 7.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
15. Pharmaceutical Biosafety Officer Training
The course is intended for Pharma Biosafety Officers (BSOs), BSOs with interest in the biopharmaceutical industry, and can be a complimentary course to Principles and Practices of Biosafety® (PPB) offered by ABSA International. The instructors will review the Biosafety Regulatory Frameworks including key regulations in the U.S. and non-US regulations and key differences between regions. This includes an Introduction to the Biorisk Management Framework and the new ISO Standard. Key topics on Applied Biosafety, including examples of new technologies in industry (e.g., CRISPR, viral vector gene therapy, others), will be discussed as well as a review of the hazard classification of human cell lines, animal blood and tissue samples, a discussion on examples of LAIs (e.g., N. meningitis, rabies), improper inactivation scenarios, and environmental release of biological agents (including a biological agent release scenario—how to handle). Good Manufacturing Practices (GMP) will be discussed including what it is, why it is important, and how to harmonize GMP and biosafety requirements. This interactive course will feature a variety of group exercises where attendees will review engineering design requirements, P&IDs, identify issues, propose recommendations for what is acceptable vs. not, HVAC design, placement and type of equipment, room pressurization, workflow, decontamination (e.g., autoclave, HEPA, kill tanks), process equipment containment. A risk assessment course will be featured as part of the group exercises where attendees will discuss how to complete a risk assessment with certain perameters, then each groups risk assessment will run through an approval process (e.g., IBC) with other groups acting as the IBC and collectively review each other’s risk assessment. The course will conclude with roundtable discussions including the group scenarious, discussions, and further Q&A.
Objectives:
- Identify the global biorisk management regulatory frameworks as applicable to pharmaceutical companies
- Restate how to harmonize GMP and biosafety, and how to integrate biosafety principles into engineering design projects (including lab and large-scale)
- Summarize how to conduct a biorisk assessment and expectations for biosafety committee approval
Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101, Principles and Practices of Biosafety® (PPB), Risk Assessment
Target Audience: All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
Rebecca McGirr, MSc, RBSO(CABS-ACSB), RBP(ABSA)
Deputy Director, Biosafety and Industrial Hygiene
Sanofi
Toronto, Ontario, Canada
Becky McGirr is currently the Biosafety and Industrial Hygiene Lead for Sanofi’s Toronto site. She holds a Bachelor’s Degree in Biology and a Master’s Degree in Neuroscience from the University of Western Ontario and has a certificate in Occupational Health and Safety. For over 8 years, Becky has worked as a biosafety professional in various settings, in both Canada and the US, including in academic and hospital-based research institutes, and in the biopharmaceutical sector. In her current role, she leads the biosafety and industrial hygiene programs at Sanofi’s Toronto campus and is the site’s biological safety officer. Becky is a member of ABSA’s Distance Learning Committee and Technical and Regulatory Review Committee. She is also a member of the Public Health Agency of Canada’s Advisory Committee on Human Pathogens and Toxins (AC-HPT). Prior to her biosafety career, Becky spent more than 10 years as a Laboratory Manager for basic research laboratories in a hospital-based research institute, specializing in molecular, cell and microbiological techniques.
Leo Njongmeta, MBA, PhD, CSP, RBP(ABSA), CBSP(ABSA)
Associate EHS Director | Global Biosafety Officer
AbbVie Inc.
North Chicago, IL
Leo Njongmeta is an Associate EHS Director and Global Biosafety Officer at Abbvie where he leads the Global R&D EHS Center of Excellence comprised of Biosafety, Vivarium Safety, Radiation Safety, Environmental Compliance and Dangerous Goods Shipping programs. His Team is responsible for providing strategic support to drive a Culture of Safety and Environmental Compliance in biomedical research, drug discovery, preclinical safety, and biologics manufacturing. Prior to a career in safety, Leo was a research scientist conducting biomedical research in the fields of immunology, animal models of infectious diseases and vaccine development. Leo possesses a B.Sc in Microbiology, an M.Sc in Molecular Biology, a Ph.D in Veterinary Science (Parasite Immunology) and an MBA in Leadership and Operations Management. Leo is currently an adjunct Assistant Clinical Professor in Environmental and Occupational Health Sciences at the University of Illinois at Chicago (UIC) School of Public Health. Leo holds board certifications in Safety (CBSP(ABSA), CSP), has been an active member of ABSA International serving in various committees which include current elected member of the ABSA Nominating Committee and leadership roles in the ABSA Pharma Biosafety Group.
Elise Franklin, MS, MBA, CSP, CIH, RBP(ABSA)
Corporate Biosafety Officer
Bristol Myers Squibb
Princeton, NJ
Elise is the Corporate Biosafety Officer for Bristol Myers Squibb (BMS) and has been with BMS for 13 years. Elise is a CIH, CSP and RBP and has 30+ years in the EHS field with experience in biopharma, biotechnology, academics, heavy industry, high technology and consulting. Her focus areas are Industrial Hygiene, Biosafety, and Ergonomics. She received her B.S. from Colorado State University, her M.S. from UMass-Lowell and her MBA from Babson.
Arif Peshimam, MSOH, MPH, MD, RBP(ABSA)
Global Head of Biosafety
Sanofi
Framingham, MA
Arif Peshimam is the Global Head of Biosafety for Sanofi, a Multinational Pharmaceutical Company. He is responsible for overall biosafety program management for manufacturing and R&D sites within the company. Prior to joining Sanofi, Arif was Corporate BSO for Southern Research, served as a Health Specialist/Industrial Hygienist in Health Safety & Environment at King Abdullah University of Science & Technology in Saudi Arabia, and was the Biosafety Officer and EHS Specialist in the Department of Environmental Health & Safety at the University of California—Riverside (UC Riverside). While at Case Western Reserve University, he implemented the Biological Safety and the Industrial Hygiene Programs from 2003 to 2008.
Arif is a Registered Biosafety Professional (RBP) with ABSA International (American Biological Safety Association) and is trained in OSHA 24-hour HAZWOPER and the National Incident Management System. He holds an MD degree from Grant Medical College in Bombay, India. He received a Master of Public Health in Environmental & Occupational Health through the Northwest Ohio Consortium for Public Health which includes Bowling Green State University and the University of Toledo. He also received a Master of Science in Occupational Health, with a major in Industrial Hygiene from the University of Toledo. He earned a master’s degree in Epidemiology and Biostatistics from Case Western Reserve University.
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 7.5 P.A.C.E.® contact hours.
Advanced Level Courses
For those with experience or looking for a challenging course.
Saturday, November 2, 2024, 8:00 AM – 5:00 PM
6. 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 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 attendee interaction and inquiries.
Objectives:
- Identify various biosafety programmatic measures and metrics that should be captured and communicated
- Paraphrase 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: Basic
COURSE FACULTY
Robert Emery, DrPH, chp, cih, csp, chmm, cpp, ARM, RBP(ABSA), CBSP(ABSA)
Vice President of Safety, Health, Environment & Risk Management
University of Texas Health Science Center—Houston
Houston, TX
Robert Emery 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. Bob is a board licensed Medical Health Physicist, a Certified Health Physicist (CHP), Certified Industrial Hygienist (CIH), and a Certified Safety Professional (CSP). He holds both ABSA International credentials; the Registered Biosafety Professional (RBP) and Certified Biological Safety Professional (CBSP).
Kristin King, DrPH, CPH, CHSP, CIC, CBSP(ABSA)
Biological Safety Manager
University of Texas Health Science Center—Houston
Houston, TX
Kristin King is the Biological Safety Program manager within Environmental Health & Safety at The University of Texas Health Science Center at Houston (UTHealth Houston).
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 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 5:00 PM
7. 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 attendees 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 engineering principles and the design and construction process of a BSL-3 laboratory
- Recall the phases and the strategies of a BSL-3 laboratory design
- Identify potential problems before construction begins
- Describe the elements of a quality assurance program
Suggested Background: None
Target Audience: All Biosafety Professionals, Operations and Maintenance Staff
Audience Level: Intermediate
COURSE FACULTY
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 vast experience in the high- and maximum containment fields 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.
Theodore (Ted) Traum has over thirty years of experience in engineering with a focus in high- and maximum containment laboratories (BSL-3 and BSL-4), biomedical facilities, hospitals and researchfacilities. In this role, he consults with clients and oversees laboratory planning, programming, commissioning, validation, and third-party certification activities for significant biocontainment, laboratory, vivarium, safety and healthcare projects. Following the September 11, 2001 attacks, Mr. Traum received a considerable influx of biosafety and biocontainment projects to combat bioterrorism. Capitalizing on his niche expertise in this fast growing industry and its previous work with the JCAHO statement of conditions, Mr. Traum focused his business development efforts towards developing acertification program for biocontainment laboratories, their design, construction, operation, biosafety consultation, and maintenance through World BioHazTec (WBHT). Being one of the only few firms in the United States with a significant level of expertise and previous success in niche projects for the healthcare and research laboratories, Mr. Traum became sought after nationally and internationally as the premier consultant for oversight, management, and certification of biocontainment facilities. Mr. Traum has consulted, reviewed, validated, and certified biocontainment laboratories, mission critical government institutions, vivaria, and world-class medical facilities. He is a highly respected professional engineer in the high- and maximum containment field and is sought worldwide for his experienceand expertise in design, construction, 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 for HVAC, mechanical, and industrial engineering issues in biocontainment, general laboratory, hospital, and vivarium projects.
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 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 1:00 pm – 5:00 pm
12. Respiratory Protection for Biosafety Professionals
This course will provide an overview of respiratory protection personal protection equipment (PPE), including selection considerations for biological and chemical hazards. A deeper dive into key hazards relevant to biosafety professionals and their respiratory protection considerations will follow. While mostly based on U.S. OSHA Respiratory Protection Program requirements, much of theinformation presented will be applicable internationally.
Objectives:
- Describe the basic process for hazard and exposure assessment necessary for selecting appropriate respiratory protection equipment
- Identify the types and styles of respiratory protection equipment, in addition to U.S. OSHA requirements for their use
- Summarize the process of respirator selection and product implementation in their workplace for key hazards
Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals
Audience Level: Intermediate
COURSE FACULTY
Kathryn Thompson, MPH, MS, CIH, MT(ASCP)
Technical Training and Education Specialist
3M
Annandale, MN
Kathryn Thompson has over 30 years of industrial hygiene experience in a variety of industrial andhealthcare applications, including infection control and technical support for disinfectant products. Kathy has been with 3M for the past 28 years and currently supports the selection and use of personal protective equipment with a focus on customers in the pharmaceutical andchemical industries. Kathy is a Certified Industrial Hygienist (CIH) and Medical Technologist MT(ASCP) with a Master of Public Health and MS in Chemistry.
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 3.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
16. Commissioning and Recommissioning for BSL-3 Containment Laboratory
By understanding the commissioning and recommissioning processes, it can assist the biosafety professional in start-up or maintaining their laboratory operations to perform the program. Laboratory commissioning, identified in containment guidance documents, is a quality assurance process for the effective functioning of biocontainment laboratories. The biosafety officer and other decision makers benefit by having a basic understanding of the commissioning and recommissioning processes and resulting documentation. This course will review the phases of the new facility commissioning process and similar process for recommissioning. This knowledge base allows the biosafety professional to recognize how commissioning assists in providing and documenting a properly operating facility. A review of the secondary containment features of the BSL-3 laboratory will be disucssed and note specific issues typically observed. There will be a focus on two issues, the reversal of directional airflow and sealing of surfaces and penetrations. Participants will consider methods to identify the issues and present some specific mitigations of these issues; can actively participate in the commissioning/recommissioning processes and understand the methodology, the tools, results, and their interpretation; will know their facility operates correctly, its limitations, and the risk when it does not. This knowledge allows the biosafety professional to check or back check the containment spaces’ performance and use this knowledge to perform daily inspections for maintenance or replacement and control risk to the lowest level. The biosafety professional can identify required features in a new laboratory or review an existing lab with a better understanding of typical issues to assure safe reliable operations.
Objectives:
- Develop an understanding of the overall commissioning and recommissioning processes for containment labs
- Articulate the engineering controls required and effectively participate in the processes
- Identify typical issues observed during commissioning/recommissioning of the laboratory secondary containment barriers and the options for practical solutions to those issues
- Demonstrate a knowledge base and provide documentation to better perform daily inspections to reduce risk for safe and reliable laboratory operations
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Operations and Maintenance Personnel
Audience Level: Intermediate
COURSE FACULTY
Joby Evans has over 35 years in facilities commissioning, support, design, engineering, energy management, and processes for consulting engineering firms, performance contracting group, natural gas distributor, and an international architect/developer. Mr. Evans is proficient in commissioning and in recommissioning high-containment facilities, analyzing the interaction between designs and energy consumption in commercial and industrial facilities and has extensive experience in building commissioning and system design and coordination. He has performed commissioning for BSL-4, BSL-3Ag, BSL-3 laboratories using BMBL, NIH, WHO, ANSI biosafety guidelines. His work has been in the United States and in international locations. Mr. Evans has performed re-commissioning and retro-commissioning on many non-containment facilities including headquarters facilities, hangers, office buildings, etc. He is a Registered Professional Engineer, Licensed Mechanical Contractor, Certified Building Commissioning Professional, Certified Energy Manager, Certified Green Building Engineer, and Guiding Principles Compliance Professional.
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 7.5 P.A.C.E.® contact hours.
VIRTUAL Offerings
(all virtual courses are in Central Time Zone)
Registration must be completed 1 business day prior to the start of the training.
Registrations received after will receive access to the recording only.
Tuesday, October 15 and Thursday, October 17, 2024, 10:00 AM – 2:30 PM CDT
1V. Plant and Arthropod Biosafety Basics
Plant research is the backbone of both genetically modified, disease resistance, and breeding of both academic and biotechnology research. Attendees will discover what is needed to design a greenhouse and lab that will contain genetically modified material and insects as well as an overview of Arthropod Containment Levels. This course will feature a diverse array of advanced scenarios and interactive exercises showcasing the spectrum of biological, genetically modified, arthropod, and other risks and hazards commonly encountered in greenhouses, fields, and laboratories supporting plant research. Attendees will be guided through strategies for identifying potential hazards, assessing the magnitude and extent of induced risks and cost, and developing effective control measures to protect the safety of workers, plants, and the environment. The course employs “real world” examples to improve understanding of greenhouse and field operations.
Objectives:
- Review risk assessment techniques as they apply to research involving genetically modified (GM) plants
- Identify and apply effective hazard and exposure control strategies into GM, arthropod lab, greenhouse design, and research facility management procedures
- Summarize strategies for safety professionals to collaborate with plant program personnel in addressing common research safety and environmental issues
Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic
Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
COURSE FACULTY
Deborah Howard, MPH, CBSP(ABSA)
Global Environment, Health, and Safety Biological Materials Manager
BASF
Durham, NC
Deborah Howard is the Expert, Global Environment, Health & Safety Biological Materials Manager for BASF where she has oversight of greenhouses, laboratories, inoculant, & fermentation sites. She has been the Biosafety Manager at BASF since May 2014. Deborah has extensive experience with IBC’s, IACUC, Select Agent regulations, exporting, greenhouse, arthropods, genetically modified plants, & animals. She has over 30 years of experience in health and safety & knowledge of regulations including NIH, OSHA, EPA, APHIS, & USDA. Previously, she was the Biosafety Manager at UNC Chapel Hill where she was the IBC Administrator for 6 years.
Anita Harrell 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.
Janet Griffiths, BS
Lab Manager – Insect and Plant Propagation Team
BASF
Durham, NC
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 North Carolina.
CONTACT HOURS
This course has been approved for 1 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 8.50 P.A.C.E.® contact hours.
Monday – Friday, October 21-25, 2024, 10:00 AM – 11:35 AM CDT
Registration is closed for this webinar. You may purchase the recording.
2V. Infectious Substance Shipping Program Management
This course is tailored for individuals responsible for establishing and overseeing infectious substance shipping programs within their facilities. This webinar series aims to assist institutions in developing robust shipping programs tailored to their needs. Course elements include: training; written policies; written descriptions of program plans; transport and shipping specific SOPs; safety and security plans; emergency response plans; logistics and supplies; carrier selection and support; MOUs and authorizations; access control and personnel assurance. The instructor will provide a detailed and comprehensive shipping program assessment and implementation guidance document. Attendees will receive an introduction to this document and step-by-step guidance on its completion. By completing the assessment document, attendees will conduct a thorough review to identify areas for improving existing shipping programs. This interactive, instructor led, web-based training will invite attendees to share examples of how these elements are addressed at their own institution.
Objectives:
- Evaluate external and internal requirements or conditions that impact shipping policies and program components at a facility, emphasizing the relevance of international regulations (ICAO TI), international standards (IATA DGR), and other guidance (CDC, WHO, CWA) for developing a robust shipping program
- Recognize the components of a shipping program and utilize provided tools and templates to assess current shipping program elements, identifying opportunities for improvement
- Compare and contrast various approaches to setting up a shipping program (centralized, decentralized, hybrid), and gain an understanding of the advantages and disadvantages associated with each
Suggested Background: IATA Infectious Substance Shipping Certification
Target Audience: Experienced Biosafety Professionals, Infectious Substance Shipping Managers & Trainers
Audience Level: Advanced
Course Length: 8 hours (five 95-minute live sessions)
Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.
COURSE FACULTY
Eric Cook, MPH
Senior Member – Technical Staff
Sandia National Laboratories
Albuquerque, NM
Eric Cook is a Senior Member of the Technical Staff in the International Biological and Chemical Threat Reduction Program at Sandia National Laboratories where his work focuses on promoting global laboratory biorisk management. He serves as one of the program’s lead trainers. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he managed the Biosafety Program and Institutional Biosafety Committee. Prior to working at Dartmouth, Eric was an Assistant Biosafety Officer at the Massachusetts Institute of Technology for six years. 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 where he worked in a recombinant DNA lab for two years assisting with work in phylogenetics. He is certified by the National Registry of Certified Microbiologists as a Specialist Microbiologist in Biological Safety Microbiology and previously by ABSA International as a Certified Biological Safety Professional. Eric has particular expertise in dangerous goods and infectious substance shipping. He worked for three years at Saf-T-Pak, Inc. developing training programs and packaging for shipping infectious substances.
COURSE FEES
ABSA Members: $720 USD
Nonmembers: $820 USD
CONTACT HOURS
This course has been approved for 1 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 8.50 P.A.C.E.® contact hours. The links to the various invitations for the course will be unique to the user and cannot be shared. The links to the various invitations for the course will be unique to the user and cannot be shared. The links are for single, individual use only.
Friday, September 13, 2024, 11:00 AM – 3:30 PM CDT
3V. 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. Course topics 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, and risk assessments for unconventional or highly specialized delivery mechanisms for biologics. 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 group 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, New Biosafety Professionals, Laboratory Workers, Research Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
COURSE FACULTY
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)
Advarra
Columbia, MD
Dan Eisenman is Executive Director of Biosafety Services at Advarra, a large clinical research compliance company. Dan heads a commercial IBC overseeing over 1,300 basic science and clinical research sites and institutions. Prior to joining Advarra Dan was the Biosafety Officer at the Medical University of South Carolina and University of North Carolina at Chapel Hill. Dan holds a PhD in Molecular Biology and Immunology as well as various biosafety certifications such as RBP(ABSA), CBSP(ABSA) and SM(NRCM). Dan also holds a Regulatory Affairs Pharmaceuticals certificate from the Regulatory Affairs Professionals Society (RAPS).
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 4.50 P.A.C.E.® contact hours.
Tuesday, September 17, 2024, 11:00 AM – 3:30 PM CDT
4V. Bio-Hazardous Drugs
The anticipated implementation of United States Pharmacopeia (USP) 800 in healthcare created a new resolve to conduct thorough risk assessments of healthcare formularies. The role of this assessment was to identify the hazards posed by these drugs, to evaluate the exposure risks associated with these hazards, and to determine the potential health consequences of both acute and chronic exposure. Most healthcare facilities that conducted these risk assessments utilized a risk matrix that incorporated criteria commonly used in toxicology to evaluate exposure to chemicals. As the pharmaceutical industry quickly turns to novel biologics to treat and/or correct disease, a risk assessment of the biological hazards associated with these novel biologics is warranted. This course will provide information on these biologics; explore the known and anticipated biological properties of each; discuss the potential these biologics have to cause infections, to be shed, to contaminate the environment, and to be transmitted to others; and will cover the pertinent controls needed to contain these biologics, to prevent inadvertent exposure to these materials, to remove them from the environment, and to ensure staff and patients are appropriately educated.
Objectives:
- Define a hazardous drug and a hazardous biologic
- Recognize the hazards, exposure risks, and health consequences posed by these hazardous drugs and hazardous biologics
- Describe pertinent healthcare and pharmacy standards concerning hazardous drugs and hazardous biologics
Suggested Background: Risk Assessment, Virology/Viral Vectors
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
COURSE FACULTY
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 4.50 P.A.C.E.® contact hours.
Friday, September 6 and Monday, September 9, 2024, 10:00 AM – 2:30 PM CDT
5V. 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. 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 interactive group activities and problem-solving sessions. The instructors are experienced laboratory animal veterinarians who are actively involved in the management, oversight, and evaluation of animal care and use programs. The primary target audience for this course are biosafety and general safety professionals with limited experience in the animal research environment.
Objectives:
- Review basic hazard identification and risk assessment techniques relevant to research involving live animals
- Develop an understanding of governing regulations and guidelines that pertain to the care and use of research animals
- Recognize 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
Susan Harper, DVM, MS, DACLAM, DACVPM, RBP (ABSA)
Private Consultant
Shepherdstown, WV
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 ABSA International; and serves on the AAALAC International Council on Accreditation.
Lesley Colby, DVM, DACLAM
Professor
University of Washington
Seattle, WA
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 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 8.50 P.A.C.E.® contact hours.