Professional Development Courses
All times listed are in CENTRAL TIME ZONE
Basic Level Courses
For those new to the profession or would like training in a particular topic.
In-Person Courses
October 13-15, 2023
CHI Health Center, Omaha, Nebraska
Friday, October 13, 2023, 8:00 AM – 5:00 PM, Room 205
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 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
PDC 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, PhD, RBP(ABSA), CBSP(ABSA)
Senior Scientist
Biosafety and Laboratory Operations
Merrick & Company
Greenwood Village, CO
Carrie Smith has served as a biosafety professional for over fourteen years in academia, the government, and the private sector. In her current role, she serves as a Senior Scientist with Merrick & Company, specializing in biosafety and laboratory operations planning for new laboratories, renovations, and laboratory transitions. Prior to her role at Merrick, she served as BSO and ARO at Oklahoma State University, a biosafety specialist and trainer at University of Wisconsin—Madison, and BSO and ARO at the USGS National Wildlife Health Center. Carrie earned her undergraduate degree in Biology with a concentration in Biotechnology from the University of Delaware and her PhD in Genetics from North Carolina State University. Her research included work with recombinant bacteria, viruses, fungi, and plants as well as biological toxins. As a biosafety professional, Carrie has managed both small and large biosafety programs and her expertise includes BSL-3/ABSL-3 oversight, atypical animals in biocontainment, select agent program management, recombinant technology, plant biosafety, diagnostic labs, and on-line and in-person training development. She serves as Co-Chair and Instructor for ABSA’s Principles & Practices of Biosafety Course and is a member of the Preconference Course Committee.
Dee Zimmerman
Biosafety Consultant
ABSA Past President-2019
Galveston, TX
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, October 13, 2023, 8:00 AM – 5:00 PM, Room 207
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 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 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
PDC 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, October 13, 2023, 8:00 AM – 5:00 PM, Room 206
3. 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; regulations, guidelines, and quality standards that primarily apply to animal research in the U.S.; 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
- 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” related 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, New IACUC and Safety Committee Members
PDC Level: Basic
COURSE FACULTY
Susan Harper, DVM, DACLAM, DACVPM, RBP(ABSA)
Deputy Director
Office of Animal Care and Use
National Institutes of Health
Bethesda, MD
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 1.0 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, October 15, 2023, 8:00 AM – 5:00 PM, Room 208
12. Introduction to the ISO35001: Biorisk Management for Laboratories and Other Related Organizations
As there is a demand for stringent and robust system for handling risks of biological materials internationally; ISO 35001 has been published as the first international standard that defines the requirements of the biorisk management system for laboratories or any other organization that works with biological agents. ISO 35001 complements existing international standards for laboratories, and is appropriate to the nature and scale of any laboratory or organization that works with, stores, transports, and/or disposes of hazardous biological materials. The commitment to follow the ISO35001 will enable institutions to effectively identify, assess, control, and monitor the laboratory biosafety and biosecurity risks associated with hazardous biological materials, using the concept of continual improvement through the PDCA (Plan-Do-Check-Act) principle. Institutions can use the standard as a framework for improving overall biorisk program performance, raising awareness, improving international collaboration and communication, fulfilling legal requirements and supporting lab certification.The course will start with an introduction to the ISO35001, brief introduction to the major sections including leadership, planning, support, operation, performance evaluation and improvement, followed by a discussion about how to initiate implementation to improve biorisk management system. Through facilitated discussions and activities, participants will leave the course with a plan of action to perform a gap analysis of their current management system with the new ISO standard and begin a stepwise implementation process to improve existing systems and qualify for eventual ISO35001 certification.
Objectives:
- Distinguish the ISO35001 as an international standard for laboratory biorisk management requirements
- Recognize the main sections of the ISO35001
- Explain how to initiate the use of the ISO35001 to improve the overall laboratory biorisk management system
- Plan a stepwise process to analyze and improve existing biorisk management systems to qualify for eventual ISO35001 certification
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals, International Biosafety Professionals
PDC 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.
Kalpana Rengarajan, PhD, MPH, JM, RBP(ABSA)
Director of Research Safety | Senior Biosafety Officer
Emory University
Atlanta, GA
Kalpana Rengarajan is the Director of Research Safety at the Environmental Health and Safety Office (EHSO) and is the Senior Biosafety Officer for Emory University. EHSO has University-wide responsibility for all aspects of Environmental Health and Safety support, including Biosafety and EHS compliance support to Emory Healthcare. This includes biosafety support to the Emory Serious Communicable Diseases Unit (SCDU), which cared for 4 Ebola patients in 2014. The SCDU continues to be a major leader in the U.S. National Ebola Training Center. Her background includes a PhD in Immunology and she has worked as a Visiting Associate at the National Eye Institute, NIH. Prior to joining EHSO she worked as a Research Associate at the Emory Vaccine Center. Kalpana has a passion for Global Biorisk Management Public Health Preparedness and provides guidance internationally. She has a Masters of Public Health from Rollins School of Public Health (Emory University) and a Juris Masters of Law (Emory University). She is a Registered Biosafety Professional. Dr. Rengarajan serves on committees for the ABSA International (American Biological Safety Association) and the Campus Safety Health and Environmental Association (CSHEMA), to create professional development courses, and is a member of the technical writing team for ISO/TC 212/Working Group 5 (ISO Laboratory Biorisk management standard), and was a technical writer for the CEN Workshop Agreements relating to Biorisk Management Systems: CWA 15793:2011 and 16393: 2012. Dr. Rengarajan regularly teaches/facilitates and presents at ABSA and CSHEMA. She has also been teaching for the Laboratory Leadership Service (LLS) program at CDC.
Rawan Khasawneh
Team Leader
Biorisk Management Training Division
Princess Haya Biotechnology Center
Jordan University of Science and Technology
Irbid, Jordan
Rawan Khasawneh is the team leader of biorisk management training division (BRMTD) at Princess Haya Biotechnology Center / Jordan University of Science and Technology. Her work focuses on developing and implementing strategic and sustainable biorisk management training on a regional basis. She is responsible for the coordination of biorisk management training events for professionals of different sectors from Jordan and the MENA region, and teaching them using interactive learning techniques. Ms. Khasawneh has implemented several projects with national and international organizations to support the building up and improvements of biorisk management system in the MENA region. In addition, she has experience in the biotechnology field in diagnostic and research labs where she used molecular techniques such as microarray, DNA sequencing, real-time PCR, and conventional PCR to study the genetics of cancer, gene expression, and detection of viral agents. She obtained her master of science in applied medical sciences from Jordan University of Science and Technology, and professional certification in biorisk management and biosecurity from the International Federation of Biosafety Associations (IFBA).
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, October 15, 2023, 8:00 AM – 12:00 PM, Room 209
16. Capturing and Displaying 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 bad 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 bad 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
- 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
- Paraphrase techniques used for displaying biosafety data in ways that others can readily understand and appreciate
Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals
PDC 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).
Scott Patlovich, DrPH, CIH, CSP, CHMM, CPH, CBSP(ABSA)
Assistant Vice President of Environmental Health & Safety
University of Texas-Houston, Houston, TX
Scott Patlovich 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).
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 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, October 15, 2023, 1:00 PM – 5:00 PM, Room 209
18. Writing Effective Standard Operating Procedures
This course will offer participants an understanding of key principles for writing effective standard operating procedures (SOPs). An introduction to the importance of SOPs in achieving desirable and consistent outcomes and issues that must be considered in the SOP writing process will be presented. Examples will include some of the most common human behavior considerations such as compliance, behavioral evolution, complaisance, and strategies to address behavioral concerns that may arise. Participants will engage in guided discussions about the benefits of an effective SOP writing process and the most common mistakes made by the authors of SOPs. The course will take participants through the process of writing feasible standard operating procedures (SOPs) including SOP evaluation and validation. Through group interactions, participants will develop examples of SOPs to illustrate effective writing concepts, present their SOPs to the class, and evaluate each other’s SOPs for feasibility. Instructors will guide participants through the process by providing critical feedback on the SOP writing process as they progress. The goal of this course is to increase students’ awareness of issues that arise when writing standard operating procedures and how these issues affect SOP compliance. Furthermore, the course will provide examples of well-written SOPs that contribute to overall SOP compliance at an institution. The course is intended for those who want to be able to lead or aid in the creation of feasible and effective SOPs in order to enhance both biosafety and biosecurity at their institution.
Objectives:
- Summarize the range of issues that must be considered when writing effective standard operating procedures (SOPs), including human behavior
- Develop strategies for writing effective SOPs
- Illustrate how good standard operating procedures (SOPs) work to enhance both biosafety and biosecurity
- Recognize the value of “feasible” and therefore effective standard operating procedure (SOP) in promoting biosafety and biosecurity best practices
Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
PDC Level: Basic
COURSE FACULTY
Natasha Griffith, MS, MPH, RBP(ABSA)
Associate Director – High Containment Core
Georgia State Universtiy
Atlanta GA
Natasha Griffith is the Associate Director, High Containment Core at Georgia State University (GSU) where she oversees design and construction of new high containment research facilities and leads a multidisciplinary team to support safe operations and maintenance (O&M) of all high containment facilities at GSU. Natasha earned her Master of Science degree in Microbial Pathogenesis and a Bachelor of Science degree in Microbiology, Immunology and Molecular Genetics from UCLA as well as Master of Public Health in Paris, France. With over 15 years of experience, Natasha has led numerous international missions in response to infectious disease outbreaks.Before joining GSU, Natasha was the Branch Chief of Quality and Safety Systems, DLS, CSELS at the CDC where she led quality and safety staff to support the development of standards, guidelines, recommendations, and tools for improved quality and safety in clinical and public health laboratories. Prior to her work at CDC, Natasha directed all high contaminant facilities at the University of California, Los Angeles (UCLA).
William Arndt, PhD
Senior Biosafety Officer
Georgia State University
Atlanta, GA
William (Bill) Arndt is Senior Biosafety Officer (BSO) at Georgia State University where he oversees biosafety and biosecurity for the GSU research community and leads a multidisciplinary team to support safe research at GSU. Bill earned his Doctor of Philosophy (PhD) degree in Microbiology from Arizona State University and a Bachelor of Science degree in Microbiology from South Dakota State University. Bill is virologist by training and subject matter expert in areas of disease surveillance, infectious disease diagnostics, incident/outbreak response, vaccine development/production, high-containment laboratory operations, biorisk management, and dual-use research of concern (DURC). He has supported the US Government health security and capacity building initiatives for 12+ years across Africa, Middle East, and Southeast Asia. Before joining GSU, Bill was a Biosafety Team Lead and International Program Lead in the Division of Laboratory Systems (DLS), CSELS at the CDC where he was responsible for managing multi-member teams and projects related to providing support to public health and clinical laboratories and development of national biosafety and biosecurity legislation, policies, regulations, and guidelines development. Prior to his work at CDC, Bill was a Principal Member of the Technical Staff at Sandia national Laboratories where he led various activities related to laboratory design best practices and outbreak response.
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, October 15, 2023, 1:00 PM – 5:00 PM, Room 213
19. Using the Past to Prevent Future Laboratory-Acquired Infections
Preventing laboratory-acquired infections (LAIs) is a challenge for laboratory managers and biosafety professionals, especially when dealing with an emerging pathogen. It is extremely important to quickly determine if there has been an exposure, what steps need to happen next, including any prophylaxis, root cause analysis, gaps in the biosafety plan, and additional mitigation measures that need to be implemented. This interactive course will demonstrate how real-life scenarios from the ABSA LAI Database can be used as a learning and training tool to help prevent future incidents and LAIs. This course will provide an overview of how to search the LAI database and a review of two published case studies. Participants will be shown how to use an exposure assessment tool and clinical laboratory biological exposure monitoring guide (both provided) to demonstrate that the database scenarios had resulted in an exposure. Participants will be shown how to perform a root cause analysis, apply this information to find the biosafety plan gaps, and determine what additional steps are needed to mitigate the risks. In a group discussion, participants will receive new scenarios from the database; utilize the exposure assessment tool to complete the process that was illustrated from exposure determination to performing the root cause analysis, identifying the gaps, and mitigation steps to help prevent this from happening again. Additionaly, participants will learn how to use published LAI data and these tools to determine how to safely work with an emerging pathogen.
Objectives:
- Describe how the ABSA LAI database can be used for biosafety training and determining how to safely work with emerging pathogens
- Utilize an exposure assessment tool to assess real-life laboratory incidents for potential exposures and to help guide prophylaxis if indicated
- Analyze actual laboratory incidents to determine the root cause and what steps are necessary to mitigate future incidents
Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience All Safety Professionals, Laboratory Workers
PDC Level: Intermediate
COURSE FACULTY
Michael Pentella, PhD, D(ABMM)
Clinical Professor | Director
State Hygienic Laboratory—University of Iowa
Iowa City, IA
Dr. Michael Pentella is a Clinical Professor at the University of Iowa, College of Public Health and Director of the Iowa State Hygienic Laboratory. His experience spans over forty years in clinical microbiology and public health laboratories. He is certified as an American Board of Medical Microbiology Diplomate, a specialist in microbiology through the American Society for Clinical Pathology, and certified in infection control through the Association of Professionals in Infection Control. Dr. Pentella is a member of the Association of Public Health Laboratories (APHL) Biosafety Committee, Antibiotic Resistance Lab Workgroup, the APHL Infectious Disease Committee, and the APHL Respiratory Viruses Subcommittee. He has made several contributions that have improved the practice of clinical microbiology and biosafety. He has written over 50 articles and twenty book chapters.
Shoolah Escott, MS, MT(ASCP)
Biosafety/Biosecurity Trainer & Consultant
Lexington, MA
Shoolah Escott is currently an independent, Biosafety, Biosecurity, and Bioterrorism Preparedness Trainer and a COVID-19 Contact Tracer with Partners In Health. She was the Biosafety Manager and ARO at the MA State Public Health Laboratory for over 2 years where she provided biosafety training and support to over 50 clinical laboratories and to internal public health laboratory staff. She worked for APHL/CDC National Laboratory Training Network, CDC Laboratory Training Branch for over 17 years developing, implementing, delivering, and presenting national training programs in biosafety, biosecurity and bioterrorism preparedness. She has a strong background in clinical microbiology and was the safety officer for the Memorial Hospital clinical laboratory. Currently, she serves on several ABSA and APHL committees. Here are a few key biosafety accomplishments: What Constitutes an Effective Biosafety Plan at the World Microbe Forum; Biosafety and Biosecurity: Minimizing the Risks in the Laboratory and Clinical Laboratory Biosafety Risk Assessment seminars presented nationally multiple times; and the lead on the initial development and revision of the Clinical Laboratory Preparedness and Response Guide.
Erin Bowles, BS, MT(ASCP)
Laboratory Network Coordinator
Wisconsin State Laboratory of Hygiene
Madison, WI
Erin Bowles is the Laboratory Network Coordinator for the Wisconsin State Laboratory of Hygiene’s Communicable Disease Division, where she provides outreach and education to more than 125 laboratories in Wisconsin in order to ensure a coordinated statewide response to any biological threats of public health importance. Her background in clinical microbiology and expertise in biosafety serve her well as a member of APHL’s Workforce Development Committee, the Sentinel Laboratory Outreach and Partnership Subcommittee, and the Sentinel Laboratory Training Special Interest Group. Some of the committee projects that she has contributed to are revisions to the ASM Sentinel Level Clinical Laboratory Guidelines and the development of risk assessment training and biosafety tools such as the “Clinical Laboratory Preparedness and Response Guide”.
Michael Perry, MS Ed
Associate Director of the Biodefense Laboratory | Alternate Responsible Official
New York State Department of Health—Wadsworth Center
Albany, NY
Michael Perry is the associate director of the Biodefense Laboratory at the New York State Department of Health – Wadsworth Center. As the ARO, APHL Biosafety and Biosecurity committee member and a member of the Wadsworth Center institutional biosafety committee, Michael has extensive training and expertise in biosafety. As part of the Global Health Security Agenda, Michael was the lead trainer for APHL’s Global Health program, developing and providing trainings in the proper use, operation, and maintenance of biological safety cabinets and biorisk management for international public health laboratorians in Africa. Over the last 10 years, Michael has conducted numerous sentinel laboratory site visit which focused on the evaluation of both laboratory biosafety which a focus on assistance with risk assessments and risk mitigation strategies.
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.
Basic Virtual Courses
August 29 – November 13
(Although these courses are a part of the 66th Annual Biosafety and Biosecurity Hybrid Conference it is not necessary to attend the conference to register for these webinars.)
Tuesday, August 29, 2023 from 11:30 AM – 4:00 PM CDT
1V. 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, 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 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 Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
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.
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.
Registration for this course is now closed. The recording of this webinar is available for purchase until November 29, 2023.
COURSE FACULTY
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)
Executive Director of Biosafety Services
Advarra
Research Triangle Park, NC
Dan Eisenman is Executive Director of Biosafety Services at Advarra, a large clinical research compliance company. Dan heads a commercial IBC with over 1,000 clinical and basic science research sites across North America. Prior to joining Advarra Dan was the Biosafety Officer at the Medical University of South Carolina and UNC Chapel Hill. Dan holds a PhD in molecular biology and immunology, various biosafety certifications (RBP, SM(NRCM), CBSP) and a Regulatory Affairs Pharmaceuticals certificate from the Regulatory Affairs Professionals Society.
COURSE FEES
ABSA Members: $440 USD
Nonmembers: $540 USD
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 4-hours of interactive instruction from a well-respected subject matter expert.
Wednesday, September 6 and Friday, September 8, 2023, 12:30 PM – 2:45 PM CDT
2V. Introduction to the Science and Biosafety of Cell and Gene Therapy Clinical Trials
The use of recombinant and synthetic nucleic acid molecules in clinical trials is growing at an explosive pace. This course is intended to introduce biosafety professionals to the science and biosafety of gene-based investigational products in clinical trials including gene-based vaccines, gene modified cellular products, gene therapy and gene editing. This course will provide an overview of molecular biology, virology and viral vectors. Participants will discuss risk assessments and best practices for dealing with risks associated with diverse types of biological hazards.
Objectives:
- Restate the basic molecular biology and microbiological principles behind gene-based vaccines, gene modified cellular therapies and gene therapies
- Summarize how to conduct a risk assessment for gene-based vaccines, gene modified cellular therapies and gene therapies
- Overview of viral vectorology (properties, uses, and risks associated with commonly utilized viral vectors)
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Research Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 4 hours (two 2-hour live sessions with a 15-minute break each session)
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.
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.
Registration for this course is now closed. The recording of this webinar is available for purchase until December 6, 2023.
COURSE FACULTY
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)
Executive Director of Biosafety Services
Advarra
Research Triangle Park, NC
Dan Eisenman is Executive Director of Biosafety Services at Advarra, a large clinical research compliance company. Dan heads a commercial IBC with over 1,000 clinical and basic science research sites across North America. Prior to joining Advarra Dan was the Biosafety Officer at the Medical University of South Carolina and UNC Chapel Hill. Dan holds a PhD in molecular biology and immunology, various biosafety certifications (RBP, SM(NRCM), CBSP) and a Regulatory Affairs Pharmaceuticals certificate from the Regulatory Affairs Professionals Society.
COURSE FEES
ABSA Members: $440 USD
Nonmembers: $540 USD
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 4-hours of interactive instruction from a well-respected subject matter expert.
Thursday, September 28, 2023, 11:30 AM – 4:00 PM CDT
4V. IBC and IRE Basics
IBC Basics is an introductory course on the function and administration of Institutional Biosafety Committees (IBCs) delivered by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP). IBC Basics will promote the professional development of those associated with IBCs by providing an opportunity to learn about the role of NIH OSP, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, and understand the range of biosafety oversight responsibilities that IBCs have under the NIH Guidelines. This course provides an overview and may be helpful for those new to the field or for those who are also interested in the Institutional Biosafety and Biosecurity Oversight Governance workshop.
Objectives:
- Summarize the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules and the USG Institutional Policy for the Oversight of Dual Use Research of Concern (DURC)
- Restate the requirements for IBCs under the NIH Guidelines and IRES under the DURC Policy
- Describe the partnership between NIH OSP and IBCs in the oversight of research subject to the NIH Guidelines
Suggested Background: None
Target Audience: New Biosafety Professionals, IBC Members, Compliance Staff
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
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.
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.
Registration for this course is now closed. The recording of this webinar is available for purchase until December 28, 2023.
COURSE FACULTY
Kathryn Harris, PhD, RBP(ABSA)
Senior Outreach and Education Analyst
Office of Science Policy
National Institutes of Health (NIH)
Bethesda, MD
Dr. Kathryn Harris works in the Office of Science Policy (OSP), Division of Biosafety, Biosecurity and Emerging Biotechnology Policy at the National Institutes of Health (NIH). For almost 20 years she has worked to develop national and regional programs of stakeholder relations, education, and outreach strategies relevant to the oversight of research with recombinant and synthetic nucleic acid molecules and research that has dual use potential. She also advises on biosafety and biosecurity policy and regulatory issues. Prior to joining OSP, she was the Biological Safety Officer at Northwestern University. Dr. Harris is Registered Biosafety Professional and a member of ABSA International (American Biological Safety Association). She was a founding member and first president of the Midwest Area Biosafety Network (MABioN). She received her Ph.D. from Cornell University and completed two years of postdoctoral training at Washington University in St Louis. Dr. Harris was the 2019 recipient of the ABSA Arnold G. Wedum Distinguished Achievement Award, for outstanding contributions to biological safety accomplished through teaching, research, service, and leadership.
COURSE FEES
ABSA Members: $440 USD
Nonmembers: $540 USD
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 4-hours of interactive instruction from a well-respected subject matter expert.
Friday, October 27, 2023, 11:00 AM – 3:30 PM CDT
6V. Selection and Use of Personal Protective Equipment (PPE)
Recent infectious disease outbreaks highlighted the need for the proper use of Personal Protective Equipment (PPE). The guidance on use of appropriate PPE varies greatly and can often be contradicting and therefore confusing to the end user. Furthermore, availability of different PPE often varies depending on the situation and location. Selection of appropriate PPE should be based on a comprehensive risk assessment that takes in consideration the different hazards present, as well as the procedures/activities to be conducted. Often times, locations where PPE is needed vary as well, from a well-controlled laboratory environment to collection room or a field location, and even in a patient room setting. Each of these situations require staff to be able to perform a comprehensive risk assessment, often in a fast-evolving situation and with a minimal understanding of specifications associated with different PPE components available to them. This course will provide overview of different PPE options available; specifications associated with each option, and address a risk assessment process for selection of appropriate PPE for different environments. The examples will include some of the most common issues and considerations when selecting PPE such as supply chain issues as well as strategies to address behavioral concerns that may arise. In groups, participants will develop risk assessment for different scenarios, present their risk assessment to the class, and evaluate each other’s PPE selection based on their risk assessment. Instructors will guide participants through the process by providing critical feedback on the PPE features and selection process as they progress. The course will go through an effective risk assessment process which is critical for proper selection of appropriate PPE. The course is intended for those who want to be able to lead or aid in the selection of appropriate PPE in order to enhance both biosafety and biosecurity at their institution.
Objectives:
- Summarize the range of issues that must be considered when selecting appropriate PPE, including human behavior
- Develop strategies for selecting appropriate PPE based on a comprehensive risk assessment process
- Recognize the value of selection and use of appropriate PPE in promoting behavioral compliance, biosafety and biosecurity best practices
Suggested Background: None
Target Audience: All Safety Professionals, Animal Caretakers, Laboratory Workers
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
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.
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.
Registration for this course is now closed. The recording of this webinar is available for purchase until January 27, 2024.
COURSE FACULTY
Natasha Griffith, MS, MPH, RBP(ABSA)
Associate Director – High Containment Core
Georgia State Universtiy
Atlanta GA
Natasha Griffith is the Associate Director, High Containment Core at Georgia State University (GSU) where she oversees design and construction of new high containment research facilities and leads a multidisciplinary team to support safe operations and maintenance (O&M) of all high containment facilities at GSU. Natasha earned her Master of Science degree in Microbial Pathogenesis and a Bachelor of Science degree in Microbiology, Immunology and Molecular Genetics from UCLA as well as Master of Public Health in Paris, France. With over 15 years of experience, Natasha has led numerous international missions in response to infectious disease outbreaks.Before joining GSU, Natasha was the Branch Chief of Quality and Safety Systems, DLS, CSELS at the CDC where she led quality and safety staff to support the development of standards, guidelines, recommendations, and tools for improved quality and safety in clinical and public health laboratories. Prior to her work at CDC, Natasha directed all high contaminant facilities at the University of California, Los Angeles (UCLA).
William Arndt, PhD
Senior Biosafety Officer
Georgia State University
Atlanta, GA
William (Bill) Arndt is Senior Biosafety Officer (BSO) at Georgia State University where he oversees biosafety and biosecurity for the GSU research community and leads a multidisciplinary team to support safe research at GSU. Bill earned his Doctor of Philosophy (PhD) degree in Microbiology from Arizona State University and a Bachelor of Science degree in Microbiology from South Dakota State University. Bill is virologist by training and subject matter expert in areas of disease surveillance, infectious disease diagnostics, incident/outbreak response, vaccine development/production, high-containment laboratory operations, biorisk management, and dual-use research of concern (DURC). He has supported the US Government health security and capacity building initiatives for 12+ years across Africa, Middle East, and Southeast Asia. Before joining GSU, Bill was a Biosafety Team Lead and International Program Lead in the Division of Laboratory Systems (DLS), CSELS at the CDC where he was responsible for managing multi-member teams and projects related to providing support to public health and clinical laboratories and development of national biosafety and biosecurity legislation, policies, regulations, and guidelines development. Prior to his work at CDC, Bill was a Principal Member of the Technical Staff at Sandia national Laboratories where he led various activities related to laboratory design best practices and outbreak response.
Vibeke Halkjaer–Knudsen, PhD
Vipsit LLC
Helsinge, Denmark
Vibeke Halkjaer-Knudsen (Vips) is a Senior Subject Matter Expert (SME) in areas related to biological and chemical risk management, incident management and response, accident and incident root cause investigations, dual-use materials, and high containment lab design. She performs multidimensional impact and risk assessments from a product, GMP, GMO, environment, health and safety, emergency preparedness, animal welfare, chemical and biological point of view. She has extensive experience with lab design and sustainable solutions on all continents. She sits in several think tanks and advisory boards, revises guidelines when needed and has a true passion for building the next generation of biorisk management professionals. She serves several of these younger individuals as a mentor, coach and provides reach back capacity when the daily tasks become too challenging. For almost 20 years, she was a Director at the Danish Statens Serum Institute, responsible for quality control labs, Tuberculin production, large scale vaccine production and facility design. She has spent the last 12 years at Sandia National Laboratories in New Mexico as Principal and later Distinguished Member of Technical Staff, working with international stakeholders, within the biorisk management non-proliferation programs funded by the U.S. Government. Since 2006, she has been consulting as a private GMP and Biorisk Management Consultant on the side while continuing to work her daytime jobs. In the autumn of 2022, she decided to focus full time on her role as an experienced project manager, supporting clients who were implementing biorisk management standards in their labs and in making risk informed decisions for sustainable laboratory design around the globe. She earned her PhD in Chemistry from the University of Copenhagen.
COURSE FEES
ABSA Members: $440 USD
Nonmembers: $540 USD
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 4-hours of interactive instruction from a well-respected subject matter experts.