Starts in:
Basic Level Courses
For those new to the profession or would like training in a particular topic.
In-person Professional Development Courses
All times listed are in MOUNTAIN STANDARD TIME
November 1-3, 2024
JW Marriott Phoenix Desert Ridge
Friday, October 24, 2025, 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 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 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 24, 2025, 8:00 AM – 5:00 PM
2. 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 three years. The course utilizes several facilitated learning activities. Attendees have opportunities to mark, label, package and complete documentation for a variety of infectious substances shipments (Category A, Category B, Exempt Patient Specimens). This course would be appropriate for those responsible for packaging, marking, labeling shipments of all categories of infectious substances, dry ice and liquid nitrogen. Attendees 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:
- Demonstrate competency to meet IATA infectious substance shipping certification requirements
- Restate and demonstrate how to properly package, mark/label, document and prepare shipments of category A and B infectious substances and other non-regulated biological materials
- Paraphrase any regulatory changes over the past several years and apply them to meet regulatory re-training requirements
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, October 24, 2025, 8:00 AM – 5:00 PM
3. Preparing for and Responding to Laboratory Emergencies – Are you prepared?
Biosafety professionals often provide fundamental training for research and healthcare staff to work safely and respond to potential emergencies involving a wide range of biological hazards. Training employees to proactively identify and take appropriate actions to minimize the likelihood and impact of these types of incidents helps to minimize the development of serious and/or irreversible consequences. This course reviews the process for developing an effective emergency response plan, emphasizing the importance of a comprehensive and well-coordinated training program for laboratory staff, institutional incident response team members, and local first responders (e.g., emergency management services, fire, police, emergency dispatchers) when biological hazards are involved. Specific topics to be addressed include: the basic components of a comprehensive institutional emergency response plan; laboratory-specific contingency plans, emphasizing unique considerations for emergencies that involve biological hazards; staff roles and responsibilities during emergencies; communication strategies and protocols during an emergency event; and training and effective preparedness exercises to ensure a coordinated response effort.
Objectives:
- Review key components of the emergency management cycle as it applies to research institutions and laboratories
- Identify the various roles and responsibilities that are critical to an effective response
- Summarize ways to coordinate and communicate effectively with institutional and local authorities during an emergency
Suggested Background: Biosafety and Biosecurity Training Course (BBTC®), Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic
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.
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.
Saturday, October 25, 2025, 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. 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. 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. This section will end with the introduction of an interactive exercise on reviewing design drawings. The instructors will lead interactive exercises and 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.
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: Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB), Risk Assessment
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.
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, October 25, 2025, 8:00 AM – 5:00 PM
6. Beginners’ Guide to Comprehensive Biorisk Management: Integrating Biosafety and Biosecurity Practices
This course provides attendees with a comprehensive foundation in biorisk management by integrating biosafety and biosecurity principles within a unified risk assessment framework. Centered around the AMP (Assessment, Mitigation, Performance) model, the course delivers practical tools for identifying, evaluating, and mitigating risks associated with the handling of biological agents and toxins. Attendees will gain a solid understanding of biosafety and biosecurity risk assessments and learn how to apply core assessment strategies effectively. Through a dynamic mix of lectures, real-world case studies, and hands-on group exercises, attendees will explore both foundational and emerging issues in biorisk management. The course emphasizes actionable strategies that can be tailored to diverse institutional environments and translated into improved safety and security practices. Attendees will conclude the course with enhanced awareness of complex biorisk scenarios and the skills to implement risk-informed mitigation measures within their own organizations.
Objectives:
- Describe the AMP model of biorisk management and utilize it to address biological risks
- Develop and implement effective risk mitigation strategies including engineering controls, administrative controls, work practices, and personal protective equipment
- Summarize how the five pillars of biosecurity support biorisk programs, inform performance evaluation and stakeholder engagement to stregthen safety culture
Suggested Background: Micro/Molecular Biology 101
Target Audience: New Biosafety Professionals, All Safety Professionals
Audience Level: Basic
COURSE FACULTY
Dr. Antony Schwartz is the Director of Biological Safety at Duke University, where he serves as the Institutional Biosafety Officer, Responsible Official for the Select Agent Program, and Institutional Contact for Dual Use Research (ICDUR). In these roles, he ensures institutional compliance with federal regulations governing biosafety, biosecurity, and dual-use research oversight. He also holds an appointment as an Adjunct Assistant Professor in the Department of Family Medicine and Community Health at the Duke University School of Medicine. Dr. Schwartz and his team oversee biological hazards across research laboratories and healthcare settings, including the Duke Regional Biocontainment Laboratory (RBL), clinical trials and microbiology labs, autopsy and gross anatomy labs, phytotrons, and arthropod containment facilities. His oversight spans BSL-1 through BSL-3/ABSL-3 spaces, including BSL-2+ and ABSL-2 environments. Prior to Duke, Dr. Schwartz was the Responsible Official for the National Institutes of Health Select Agent Program in Bethesda, Maryland. He was previously a postdoctoral fellow in the National Biosafety and Biocontainment Training Program (NBBTP), a competitive, in-residence fellowship at NIH designed to prepare professionals to manage BSL-3 and BSL-4 laboratories handling high-risk pathogens such as Ebola, Monkeypox, and Nipah virus. He has also served as a BSL-4 instructor and course facilitator at NIH and NIAID facilities. Dr. Schwartz holds a PhD in Microbiology with a minor in Technology Commercialization. A Certified Biological Safety Professional (CBSP) through ABSA International, Dr. Schwartz has held numerous leadership roles in the organization, including Councilor, Chair of the Pre-Conference Course Committee, Vice Team Lead for the Regulatory and Technical Affairs Team, Journal Board Reviewer, and Co-Chair of the inaugural Biosecurity Symposium Steering Committee. He remains actively engaged in biosafety and biosecurity through research, publications, professional outreach, and mentorship.
Dr. Andrea Vogel is currently a Safety and Health Specialist in the Biological Safety Division of the Occupational and Environmental Safety Office at Duke University Health Systems. She is also an Alternate Responsible Official for the Select Agent Program. The Biological Safety Division oversees programs implemented for mitigating biological hazards at Duke University, Duke University Hospital and Clinics. Programs she oversees include the Bloodborne Pathogens Exposure Control Program, Tuberculosis Control Program, and the BSL-3 Laboratory Program. Dr. Vogel has been a member of ABSA International since 2021 and is an active member of the Journal Board, Finance Committee, Awards Committee, and Pre-Conference Course Committee. Her interests include biosafety/biosecurity program management, risk assessment of emerging infectious diseases and technologies, and application of technology to enhance understanding in training programs. Dr. Vogel received her PhD in Genetics from North Carolina State University, and was a NIH NBBTP Fellow. She has authored several papers ranging from validation of hydrogen peroxide vapor to facilitate re-use of N95s to animal behavior and group coordination.
CONTACT HOURS
This course has been approved for 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, October 25, 2025, 8:00 AM – 12:00 PM
10. The Big Bright Beautiful World of BSL-2
Ever wondered why handling human blood samples and culturing infectious influenza both require BSL-2 containment? Or the defining characteristics between BSL-2 and BSL-1 or BSL-3? This course transforms biosafety from a checklist into a strategic risk management framework, adaptable to any facility or resource level. We’ll go beyond textbook scenarios, tackling the gray areas of BSL-2 where critical thinking and adaptability are key. Starting with a rapid refresher on core biosafety principles, we’ll explore how to adjust BSL-2 containment ‘levers’ for real-world applications, even in non-ideal or resource-limited labs. This course isn’t just about following rules—it’s about understanding why they exist. Attendees will explore key topics in biosafety, including distinctions and special considerations of BSL-2 and ABSL-2, the critical difference between regulations and recommendations on lab operations, compare global biosafety guidelines with the BMBL, safe handling of RG-3 agents in BSL-2 settings, emerging BSL-2+ practices, and real-world case studies—such as HIV and SARS-CoV-2—through interactive activities. This course empowers new biosafety professionals to move beyond a rigid, one-size-fits-all approach. Attendees will develop the confidence to make informed, customized containment decisions—becoming strategic biosafety leaders in their field.
Objectives:
- Utilize the BMBL as a framework and move beyond a checklist approach and apply adaptive biosafety practices in diverse laboratory settings, including resource-limited or non-ideal facilities
- Explain BSL-2 containment principles and practices and how this relates to “BSL-2+” containment and allows for the handling of Risk Group 3 agents under BSL-2 conditions
- Adapt the foundation necessary to confidently make non-textbook containment recommendations that will meet BSL-2 recommendations and keep researchers safe
Suggested Background: None
Target Audience: New Biosafety Professionals, All Safety Professionals, Animal Caretakers
Audience Level: Basic
COURSE FACULTY
Heidi has extensive experience in, and passion for, the ‘grey zone’, intertwining regulation, safety and human behavior to find the best overall solutions to the safety and compliance challenges we face when doing research. Heidi has 15+ years of experience in the field of biosafety and has over 7 years of experience serving as the Biological Safety Officer and Assistant Director of Environmental Health and Safety at Case Western Reserve University. She earned a BS in Organismal Biology from the University of Kansas, a MS in Cell and Molecular biology from University of Missouri—Kansas City and is a Registered Biosafety Professional with ABSA International. In her role as the Director of Sabai’s Shield Consulting group, Heidi has the opportunity to work with varied clients from academic institutions, CROs, startup biotechs, large pharma, and healthcare institutions. Outside of work Heidi is often found trying her hand at something new, be it gardening, cooking, raising chickens or keeping bees. She feels passionately that there is always something new to learn.
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, October 25, 2025, 1:00 PM – 5:00 PM
11. Writing Effective Standard Operating Procedures
This course will offer attendees 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. Attendees 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 attendees through the process of writing feasible standard operating procedures (SOPs) including SOP evaluation and validation. Through group interactions, attendees 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 attendees through the process by providing critical feedback on the SOP writing process as they progress. The goal of this course is to increase attendees’ 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
- Identify 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: Fundamentals of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers, International Attendees
Audience Level: Basic
COURSE FACULTY
Natasha Griffith is the CEO of SOTER Bio Consulting, where she leads different national and international projects in response to health emergencies. She also serves as Associate Director, High Containment Core at Georgia State University (GSU) where she leads a multidisciplinary team to support safe operations and maintenance (O&M) of all high-containment facilities (BSL-3, ABSL-3, and BSL-4) 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 20 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. While at the CDC, Natasha also implemented and managed international projects in response to outbreaks of infectious diseases in various countries. These projects included development of program initiatives for a variety of local, national and international public health institutions in both English and French. Prior to her work at CDC, Natasha established and operated a state-of-art Tier 1 Select Agent high-containment program at UCLA. For over a decade, Natasha directed all high-contaminant facilities and served as the Responsible Official (CDC DSAT) for all select agent research at the University of California, Los Angeles (UCLA).
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.
Dr. Asadulghani has been working in the field laboratory systems strengthening using One Health platform in Bangladesh since 2010, with 14 years’ experience of research in the field of Molecular Genetics and Bacteriophage Biology, at home and abroad, since 1993. He has an MSc and MPhil in the field of Molecular Genetics, from the University of Dhaka. He has a PhD, in the field of post-transcriptional regulation of genes expression, from the Saitama University, Japan in 2004. Completing his postdoctoral research as a Research Associate and JSPS Postdoc Fellow, at the University of Miyazaki, Japan, he joined as an Assistant Professor in the Division of Microbiology and continued working in the Microbial Whole Genome Sequencing Group, Japan. Since September 2009, he has been working as the Head of Biosafety, leading biosafety and biosecurity program, at the International Centre of Diarrhoeal Disease Research, Bangladesh (ICDDR,B). Side by side, he is leading the nationwide Biosafety and Biosecurity (BSBS) program, as well. He is leading strengthening AMR laboratory capacity program under the First Fleming Fund Country Grant to Bangladesh. He is also the lead for “Qualifying Workforce for AMR Surveillance in Asia and Africa” in Bangladesh. He is the initiator of the BSBS program in Bangladesh and working for strengthening country status. He has been working for ISO 15189 accreditation of Clinical Laboratory Services at ICDDR,B since 2010, and solely contributing to ISO 15190 accreditation of the same since 2016. He is a member of the ISO Biorisk Management working group ISO/TC 212/WG5 representing IFBA. He is the Chairman and Coordinator of Training of BBBS and President of the FABA. Furthermore, he is the EXCO member of A-PBA for 2024 to represent Bangladesh. He was a Member of the Board of Directors of IFBA until September 2020. Currently, he is a member of the ABSA International Engagement Committee.
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 26, 2025, 8:00 AM – 5:00 PM
14. Facility Commissioning and Recommissioning for the BSL-3 Laboratory
The biosafety professional can assist with the start-up or maintenance of laboratory operations in support of their biosafety programs by understanding the commissioning and recommissioning processes. 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. Attendees 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.
Sunday, October 26, 2025, 1:00 PM – 5:00 PM
19. Boots on the Ground: Developing Field Laboratories in Resource-Limited Settings
This course provides attendees with the knowledge and practical skills needed to conduct research and clinical trials in international settings. It covers key aspects of fieldwork, including ethical considerations, cultural competency, regulatory requirements, data collection methods, and logistical challenges. Attendees will explore case studies and participate in hands-on training to develop strategies for navigating diverse healthcare environments, working with local stakeholders, and ensuring compliance with global research standards. Attendees will conclude the course equipped to design and implement field research projects in international contexts, addressing real-world health challenges while upholding scientific integrity and ethical responsibility.
Objectives:
- Design and Plan Fieldwork—Create a research or clinical trial protocol that includes logistics, site selection, stakeholder collaboration, and risk mitigation
- Manage Challenges in Global Research—Identify and develop solutions for common challenges such as regulatory approvals, weather emergencies, infrastructure limitations, and data security
- Implement Data Collection Methods—Utilize appropriate qualitative and quantitative data collection techniques suited for international and resource-limited settings
Suggested Background: None
Target Audience Laboratory Workers, All Safety Professionals
Audience Level: Basic
COURSE FACULTY
Krystle Hensley is the BSL4 Manager at the National Bio and Agro-Defense Facility (NBAF), a critical facility within the Agricultural Research Service of the USDA. In this role, she helps facilitate the standup of the BSL4 program and maximum containment research related to zoonotic and emerging diseases and agricultural threats. Prior to joining NBAF she worked at the Integrated Research Facility – NIAID supporting international programs and clinical trials, as well as establishing laboratory capacity in West Africa. She holds a Master of Public Health and Tropical Medicine from Tulane University and has experience in BSL3 and BSL4 research laboratories. Krystle is dedicated to advancing knowledge and contributing to cutting-edge scientific efforts to protect against emerging infectious diseases and biological threats.
Dr. Gene Olinger is Professor of Microbiology & Immunology and Director of the Galveston National Laboratory (GNL) at UTMB, one of the largest maximum containment laboratories in the United States. A leading expert in biosafety and biosecurity, Dr. Olinger brings extensive experience in the safe operation and oversight of high- and maximum containment laboratories. He is ISO 35001 and ISO 9001 Lead Auditor trained, with a strong focus on biorisk management systems and quality assurance. Throughout his career, he has led multidisciplinary teams in developing and implementing biosafety practices that support research on high-consequence pathogens. As GNL Director, he continues to advance international standards for biosafety and biosecurity while fostering global collaborations to strengthen preparedness and response to infectious disease threats.
Dr. Chad E. Mire serves as the NBAF Research Leader for the Foreign Anthropod-Borne Animal Diseases Research Unit under the United States Department of Agriculture (USDA). Prior to joining the USDA, Dr. Mire has worked at the University of Texas Medical Branch Department of Microbiology and Immunology (UTMB) for nearly a decade. Here, Dr. Mire took on several positions including Associate Professor and High-Containment Program Coordinator for Animal Research. As an Associate Professor, Dr. Mire developed research ideas in diagnostics, animal model development, vaccine, and therapeutic development in relation to emerging and zoonotic pathogens such as Ebola virus, Marburg virus, and Nipah virus. Dr. Mire received his Bachelor of Science in Biology from Rowan University, followed by receiving his Doctorate in Molecular Sciences with a focus on Virology from the University of Tennessee Health Science Center. In addition to his educational and employment history, Dr. Mire has been internationally recognized for performing leading research on emerging pathogens to develop preventative measures against emerging and zoonotic pathogens.
Dr. Lisa Hensley serves as the research leader for the Zoonotic and Emerging Disease Research Unit, or ZEDRU, located at the National Bio and Agro-Defense Facility (NBAF), which is operated by the U.S. Department of Agriculture (USDA). Dr. Hensley’s team at NBAF focus research efforts on zoonotic and emerging pathogens in large livestock and look for ways to interrupt or stop diseases, which is something USDA scientists cannot do anywhere else in the U.S. at the highest level of biocontainment or BSL-4.Before joining the USDA team at NBAF, Dr. Hensley served as the associate director for science at the National Institutes of Health’s Integrated Research Facility in Frederick, Maryland, where she was responsible for developing and managing a multidiscipline/multifaceted research portfolio supporting biodefense, potential pandemic pathogens, and emerging infectious disease research.Dr. Hensley also served as the director of regulatory science for the Medical Countermeasures Initiative in the Office of the Commissioner at the Food and Drug Administration and was the chief of Viral Therapeutics at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). She has an extensive background in public health, obtaining her doctorate at the University of North Carolina at Chapel Hill and a master’s degree in immunology and infectious disease from The Bloomberg School of Public Health, Johns Hopkins University. She spent the last 25 years developing and characterizing animal models for high-consequence and emerging pathogens, including Ebola and Marburg, SARs, MERs, Variola, mpox (formerly monkeypox) and other viruses. She used these models to develop, evaluate and help advance candidate countermeasures, including therapeutics, post-exposure prophylaxes, vaccines, and diagnostics to improve national and global health.Beyond the confines of the maximum containment laboratory, Dr. Hensley worked in remote locations such as West and Central Africa, where she established research laboratories to respond to outbreaks and conduct clinical trials in low-resource environments. She is considered one of the world’s leading subject matter experts on emerging diseases and high-consequence pathogens. She is one of few scientists with experience in the development of medical countermeasures from discovery topre-clinical evaluation and through clinical trials. Dr. Hensley has authored over 250 peer-reviewed scientific papers and book chapters and holds multiple patents.
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 26, 2025, 1:00 PM – 5:00 PM
20. No Resources? No Problem! A Dynamic Workshop for Improving Biosafety Program Visibility and Leadership Engagement
Building a holistic and comprehensive biorisk management program requires serious leadership commitment across your organization in order to drive successful mitigation strategies and compliance metrics. Biosafety Officers alone cannot develop, maintain, or continuously improve safety programs and require infrastructural support both within safety verticals as well as externally across divisions. It’s easy to lose sight of key objectives and results when faced with a mountain of operational issues, frustrated by a lack of resources, and feeling disconnected from leadership. Where do you begin when standing up a new biosafety program? What about implementing enterprise risk management solutions to mature an existing one? What are the pitfalls to avoid and how do you strategically engage leadership? This course will reinforce cornerstone pieces of biosafety program management with four highly interactive hands-on exercises to help drive solutions at your respective institutions. These exercises include leading indicator metrics, SOAR analysis, accountability and responsibility, and how to use appreciative inquiry as a tool for continuous improvement.
Objectives:
- Critique your respective biosafety program’s strengths and opportunities for improvement, both short and long term, and how to drive leadership engagement for support
- Establish a solutions-oriented approach that include leading indicator metrics based on SMART principles (specific, measurable, attainable, relevant, time-bound).
- Participate in hands-on exercises (4) and a discussion to foment tangible strategies to bring back to your institution, with a special emphasis on responsibility and accountability in safety program management
Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic
COURSE FACULTY
AJ serves as the Global Director of Biosafety and Toxicology at FUJIFILM Diosynth Biotechnologies and is part of the global quality leadership team. In this critical role, he oversees safety operations for both patients and workers across 6 campuses spanning Europe and North America, assisting in and harmonizing hazard identification, risk assessment, risk mitigation, and risk monitoring strategies. AJ describes his role as a “safety diplomat” across the company’s operations landscape, with his core belief that a successful safety leadership position is predicated on collaborating with stakeholders across scientific, operational, quality and environmental health and safety (EHS) infrastructures, as well as both engaging and empowering leadership. Before joining FUJIFILM Diosynth Biotechnologies, AJ worked in various capacities as a biosafety and operations consultant in the Greater Boston, MA area and across the United States. He has audited, inspected, or provided gap analyses for laboratories at numerous multinational life science corporations, academic institutions, biotechnology start-ups, as well as various government agencies. He received his BS in Microbiology and Classics from the University of New Hampshire, a PhD in Biomedical Science with a concentration in Molecular Biology and Biophysics from the University of Connecticut Health Center and a MS in Clinical Toxicology through the University of Florida. AJ is a Registered Biosafety Professional with the American Biological Safety Association (ABSA International), and a member of ABSA’s Scientific Program Committee. A passionate safety advocate, AJ is active in both biosafety and toxicology professional organizations globally, and lives in the Boston, MA area.
As the Global Biosafety Officer for FUJIFILM Diosynth Biotechnologies, Colleen brings a wealth of experience and expertise in biorisk management, cell & viral gene therapy, and GMP operations. In this role, she serves as a centralized subject matter expert to assist in all aspects of contract development and manufacturing (CDMO) operations surrounding biologically derived therapeutics, specifically: new product introductions, risk assessments, training, and regulatory compliance. Colleen previously served as the Lead Biosafety Officer for Spark Therapeutics, overseeing capital investment projects like their new Gene Therapy Innovation Center, scaling their AAV commercial platform, and was a pivotal SME in the success of Luxturna®, the first ever FDA approved viral gene therapy for the treatment of inherited retinal dystrophy. Previous to this, she worked as the biosafety officer at the University of Pennsylvania where she partnered with Dr. Carl June on the first ever CAR-T Cell therapy, Kymriah®. Colleen has a B.S. in neuroscience from Penn State University, holds a Ph.D. in Neuroscience from the University of Pennsylvania, is a registered biosafety professional though the American Biological Safety Association (ABSA International), and is the chair of ABSA’s Scientific Program Committee. She currently lives in Philadelphia, PA with her husband and 7-year-old son, as well as their Boston Terrier puppy, Millie.
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.
Virtual Professional Development Courses (webinars)
All times listed are in CENTRAL TIME ZONE
September 6 – October 25
These courses are part of the Professional Development Program for the 67th Annual Biosafety and Biosecurity Hybrid Conference. It is not necessary to be a conference participant to register for these courses.
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.
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.
Wednesday, October 9 and Friday, October 11, 2024, 11:00 AM – 3:30 PM CDT
7V. 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
- Identify viral vectorology (properties, uses, and risks associated with commonly utilized viral vectors)
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals, Research Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
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 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.50 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. If more than one occurrence of an individual’s name is on the Zoom attendee list or a name not of the roster, all instances will be removed from the webinar with no refund. The webinar and its associated links are for single, individual use only.
Thursday, October 3, 2024, 10:30 AM – 3:00 PM CDT
8V. IBC 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.
Objectives:
- Summarize the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules
- Restate the requirements for IBCs under the NIH Guidelines
- 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)
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.
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.