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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, November 1, 2024, 8:00 AM – 5:00 PM

1. BSL-3 Operations and Management

This course will review the important aspects of BSL-3 Operations and Management from two points of view; “hardware” (i.e., facilities & equipment issues) and “software” (i.e., administrative controls). It will cover various aspects you need to consider in order to operate a BSL-3 facility, such as training, maintenance support, occupational health, waste management, maintenance, performance verification, and emergency response. The instructors will encourage interaction and the exchange of experiences among the attendees. Regulatory aspects from any specific country, or planning, design, or construction-related issues will not be covered.

Objectives:

  • Describe the elements of BSL-3 Operations and Management (risk management, primary barriers, annual performance verification, emergency response, etc)
  • Recognize institutional, management, and user responsibilities
  • Summarize approaches to developing manuals, SOPs, and training

Suggested Background: Basic Risk Assessment and familiarity with BSL-3 Concepts
Target Audience: Safety Professionals, BSL-3 Managers, Containment Engineers, Lab and Scientific Directors

Audience Level: Basic

COURSE FACULTY

J. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA), Cornell College of Veterinary Medicine, Ithaca, NYJ. 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 A. Smith, PhD, RBP(ABSA), CBSP(ABSA), Merrick & Company, Greenwood Village, COCarrie A. Smith, PhD, RBP(ABSA), CBSP(ABSA)
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, Galveston, TX, ABSA Past President 2019
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, November 1, 2024, 8:00 AM – 5:00 PM

2. IATA Infectious Substance Shipping Certification

This course is appropriate for those who have some experience with infectious substance handling or shipping but may not have been certified within the past 3 years and those with little to no previous training. The course utilizes several facilitated learning activities. There will be group discussions and interactive exercises focused on the essential areas of infectious substance shipping. New IATA requirements for competency assessment will be administered short interactive assignments, and an online exam. Participants will mark, label, package, and complete documentation for infectious substance shipments (Category A, Category B, and Exempt Patient Specimens), and review applicable regulations with a focus on IATA. Additional U.S. DOT differences will also be addressed. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. Participants have both an online exam (score at least 80%) and practical exercises to complete to demonstrate competency. Successful completion of the course will qualify attendees for IATA/DOT certification.

Objectives:

  • Review and restate shipping regulations for both air and ground with a particular focus on 49 CFR US DOT and IATA air regulations
  • Conduct a risk assessment and be able to properly classify and identify infectious substances for transport purposes
  • Package, mark, label, and prepare documentation for shipments of infectious substances to meet regulatory requirements for air and ground shipments

Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

COURSE FACULTY

Eric Cook, MPH, Sandia National Laboratories, Albuquerque, NM
Eric Cook, MPH
Senior Member – Technical Staff
Sandia National Laboratories
Albuquerque, NM

Eric Cook is a Senior Member of the Technical Staff in the International Biological and Chemical Threat Reduction Program at Sandia National Laboratories where his work focuses on promoting global laboratory biorisk management. He serves as one of the program’s lead trainers. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he managed the Biosafety Program and Institutional Biosafety Committee. Prior to working at Dartmouth, Eric was an Assistant Biosafety Officer at the Massachusetts Institute of Technology for six years. While at MIT, Eric completed his Master’s Degree in Public Health at Boston University with a focus on Environmental Health. Eric has a B.S.in Molecular Biology from Brigham Young University where he worked in a recombinant DNA lab for two years assisting with work in phylogenetics. He is certified by the National Registry of Certified Microbiologists as a Specialist Microbiologist in Biological Safety Microbiology and previously by ABSA International as a Certified Biological Safety Professional. Eric has particular expertise in dangerous goods and infectious substance shipping. He worked for three years at Saf-T-Pak, Inc. developing training programs and packaging for shipping infectious substances.

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.

Friday, November 1, 2024, 8:00 AM – 5:00 PM

3. Basic Risk Assessment

Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the practices and containment necessary to avoid exposure to hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary to perform risk assessments for working safely with pathogens (human and animal) and rDNA (genetically modified organisms or viral vectors). Using case studies, attendees will work together to conduct risk assessments by determining the hazards involved; the appropriate questions to ask to address the potential risks associated with the intended activities and make recommendations on appropriate containment and practices required to work safely. Each group will present their conclusions from the activity.

Objectives:

  • Identify and list determinants for assessing risk (host, environment, agent)
  • Complete the steps of a risk assessment and determine steps to manage risk (mitigation)
  • Identify resources and references for risk assessment/management

Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

COURSE FACULTY
CONTACT HOURS

David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)
Safety and Occupational Health Manager
Office of Management, Center for Veterinary Medicine
U.S. Food and Drug Administration

Dr. David Harbourt is a Safety and Occupational Health Manager for the Center of Veterinary Medicine at the U.S. Food and Drug Administration (FDA). Prior to his current position, he served as the Program Director of the National Biosafety and Biocontainment Training Program (NBBTP) at the National Institutes of Health. Before that, he served in a variety of roles at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) including Biosafety Officer, Chief of the Biosafety Division and Deputy Director of the USMARIID Transition Office (2012-2021). Prior to working at USAMRIID, he was a fellow in the NBBTP. Preceding the fellowship, he graduated with his B.S. in Biochemistry from Virginia Tech (’05) and his Ph.D. in Toxicology from UNC-Chapel Hill (’09).

Dr. Harbourt has been an active member of ABSA International since 2010; has previously served as the Chair of the Preconference Course Committee and Chair of the Training Tools and Resources Committee; and currently serves as a member of the Exam Development Board for the CBSP Exam. He has also been a member of the Standards Committee, Professional Development Team, and BSAT Community Advocate Committee for ABSA. He has recently been named Co-Chair of the ABSA Ambassadors Committee. Locally within the Chesapeake Area Biosafety Association, Dave has been a Councilor, Chair of the Scientific Program Committee for its annual symposium, and Chair of the Pre-Symposium Committee. Previously, Dr. Harbourt served as Chair of the DoD Biosafety and Scientific Review Panel.

Dr. Harbourt has published several articles on topics relevant to biosafety including bacteriology, virology, agent inactivation, effluent decontamination systems, and risk assessment. He has also taught courses both at ABSA and at local universities on biosafety, risk assessment, emergency management, and effluent decontamination systems. Dave is a Registered Biosafety Professional and Certified Biological Safety Professional through ABSA International and a Specialist Microbiologist (NRCM) through the American Society of Microbiology.

Rachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA), Pond & Company, Peachtree Corners, GARachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA)
Pond & Company
Peachtree Corners, GA

Rachel is the Associate Director of Biorisk Management Programs within the Life Sciences practice at Merrick. She holds a Doctor of Public Health in Occupational and Environmental Health Sciences (concentration in epidemiology and disease control) from The University of Texas School of Public Health. In addition to her degrees, she has held the CBSP credential since 2011, and has over 18 years of experience in the field. Previously, Rachel served as the Director of the Office for Environmental Safety and the high containment/select agent research facility at Baylor College of Medicine (BCM). She was also an assistant professor in the Molecular Virology and Microbiology department. Since her departure from BCM and joining Merrick, she has diversified and grown her knowledge and experience base by working on projects for the USDA, Department of Homeland Security, Public Health Ontario, Centro Medico NAVAL (CEMENAV), NASA, Biosecurity Engagement Programs in the East Asia Pacific Region, MD Anderson Cancer Center, NIH, Labs Canada, and various colleges and universities across the United States.

Katie George, PhD, MPA, RBP(ABSA)Katie George, PhD, MPA, RBP(ABSA)
Associate Partner and Human Gene Therapy Biosafety Officer
Clinical Biosafety Services
Chesterfield, MO

Katie George lives in Missoula, Montana and is currently an Associate Partner and Human Gene Therapy Biosafety Officer for Clinical Biosafety Services (Chesterfield, MO) working with clinics, universities, and hospitals in the United States and Canada prepare for IBC review of Human Gene Therapy (HGT) clinical trials.

Katie holds a BS in Biology from the University of Iowa, a PhD in Biochemistry from Northwestern University, and an MPA from Purdue University. After obtaining her PhD, she was a post-doctoral fellow at the National Institutes of Health researching mycobacterial pathogenesis. After her post-doctoral position, she served as faculty at the University of Montana teaching and leading a research team studying organophosphate pesticide toxicology. Later, she taught medical students at the Medical University of the Americas (Nevis, West Indies). During her career, Katie has worked as a toxicology consultant for the State of Montana Public Defenders and the State of Montana Department of Public Health and Human Services.

Katie has been an ABSA member since 2020 and a Registered Biosafety Professional since 2021. She currently serves on the Distance Learning Committee for ABSA International.

Berenice Arriaga, CBSP(ABSA), SM(NRCM)
University of Texas at El Paso
El Paso, TX

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

5. Facilities Fundamentals for Biosafety Professionals

This course is aimed at strengthening biosafety professionals knowledge of how facility operations support overall biocontainment operations. The first portion of the course will familiarize attendees with the general concepts biosafety-related facility design and their roles in it, along with the fundamentals of HVAC system operation in the context of BSL-2 and BSL-3 facilities. Topics in this portion of the course include: the role of biosafety personnel in biocontainment facility design, renovation, and operations, understanding design drawings and related construction documents, what the relationship is of facility features to biosafety levels, and HVAC components and their function relative to biocontainment. The instructors will lead discussions of more detailed aspects of containment facilities and their operation, including: specific infrastructure, equipment, and systems related to operation of a biocontainment facility; autoclave function, waste management, associated facility infrastructure; room decontamination in relation to facility components; interactions between facilities and containment equipment; security, operations, and biosafety. Through a mixture of presentations from experts in the field and interactive exercises, attendees will reinforce their knowledge of facility system function and their roles in facility design, construction, and operation. The target audience for the course is biosafety professionals who come with backgrounds other than facilities, and it is open to both newcomers and seasoned veterans in the field.

Objectives:

  • Restate the roles of biosafety professionals in facility design and operation
  • Explain practical approaches for reviewing design documents.
  • Describe the function of discrete facility infrastructure, equipment, and systems related to biocontainment facility operations

Suggested Background: BSL-3 Operations and Management, Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB)

Target Audience: All Biosafety Professionals, All Safety Professionals

Audience Level: Basic

COURSE FACULTY

J. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA), Cornell College of Veterinary Medicine, Ithaca, NYJ. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA)
Biosafety Engineer
Director of Biocontainment Operations
Cornell College of Veterinary Medicine
Ithaca, NY

Paul Jennette holds Bachelor’s and Master’s Degrees in Environmental Engineering from Cornell and the University of Massachusetts, respectively, and is both a Registered Professional Engineer and a Certified Biological Safety Professional. Since 1999, he has held the position of Biosafety Engineer at the Cornell College of Veterinary Medicine and has also been the Director of Biocontainment Operations there since 2013. Paul’s responsibilities include: design, verification, operation, decontamination, and program management related to Cornell’s BSL-3, ACL-3, and ABSL-3 facilities, which include both research & diagnostic laboratories as well as a BSL-3 large animal necropsy; training all Cornell BSL-3 scientific and support staff and providing direct, in-containment support for BSL-3 diagnostic operations; directing the operations of Cornell’s medical and pathological waste treatment facility, which includes a 5,000-lb/batch carcass digester; serving on Cornell’s Institutional Biosafety Committee and directing the Cornell Vet College Rabies Risk Management Program. Paul serves on biosecurity teams for Select Agent Labs at the Cornell Vet College and provides technical support for the College’s effluent decontamination systems. He served as the American Biological Safety Association’s representative on the ANSI committee to develop a national standard for the verification of BSL-3 facility performance, is a reviewer and lead author of a technical column for the Applied Biosafety journal, and is a member of ABSA’s Professional Development Team. He is a former co-chair of ABSA’s Principles & Practices of Biosafety class as well as a regular instructor for BSL-3 courses offered by the Eagleson Institute and ABSA. In addition to his position at Cornell, Paul provides biocontainment operations consulting services to a variety of academic, governmental, and pharmaceutical clients.

Rachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA), Pond & Company, Peachtree Corners, GARachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA)
Pond & Company
Peachtree Corners, GA

Rachel is the Associate Director of Biorisk Management Programs within the Life Sciences practice at Merrick. She holds a Doctor of Public Health in Occupational and Environmental Health Sciences (concentration in epidemiology and disease control) from The University of Texas School of Public Health. In addition to her degrees, she has held the CBSP credential since 2011, and has over 18 years of experience in the field. Previously, Rachel served as the Director of the Office for Environmental Safety and the high containment/select agent research facility at Baylor College of Medicine (BCM). She was also an assistant professor in the Molecular Virology and Microbiology department. Since her departure from BCM and joining Merrick, she has diversified and grown her knowledge and experience base by working on projects for the USDA, Department of Homeland Security, Public Health Ontario, Centro Medico NAVAL (CEMENAV), NASA, Biosecurity Engagement Programs in the East Asia Pacific Region, MD Anderson Cancer Center, NIH, Labs Canada, and various colleges and universities across the United States.

Steve Helgren, AIA, NCARB
Merrick & Company
Greenwood Village, CO

Fahim Manzur, RBP(ABSA)
Merrick & Company
Greenwood Village, CO

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.

Saturday, November 2, 2024, 8:00 AM – 5:00 PM

6. Articulating the Value of Your Biosafety Program

A recurrent challenge confronting biosafety professionals is the ability to garner necessary program resources to achieve desired goals and objectives. The basis for this difficulty is that, on a good day in the world of biosafety, “nothing happens”. The underlying challenge is that upper management may not fully appreciate or understand all the effort and resources that went into making “nothing happen”. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course focuses on some key management approaches and techniques that can be used within biosafety programs to help improve stakeholder understanding, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques presented will be displayed for review and discussion. Ample time will be provided throughout the course for attendee interaction and inquiries.

Objectives:

  • Identify various biosafety programmatic measures and metrics that should be captured and communicated
  • Paraphrase the techniques that can be used for displaying biosafety data in ways that others can readily understand and appreciate it
  • Describe how biosafety programs can assist with other basic safety program needs to help avoid the notion of program duplication of efforts and to improve safety and client satisfaction levels

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals

Audience Level: Basic

COURSE FACULTY

Robert Emery, DrPH, RBP(ABSA), CBSP(ABSA), University of Texas-Houston, Houston, TX
Robert Emery, DrPH, chp, cih, csp, chmm, cpp, ARM, RBP(ABSA), CBSP(ABSA)
Vice President of Safety, Health, Environment & Risk Management
University of Texas Health Science Center—Houston
Houston, TX

Robert Emery is Vice President for Safety, Health, Environment & Risk Management for The University of Texas Health Science Center at Houston (UTHealth Houston) and Professor of Occupational Health at the University of Texas School of Public Health. Bob is a board licensed Medical Health Physicist, a Certified Health Physicist (CHP), Certified Industrial Hygienist (CIH), and a Certified Safety Professional (CSP). He holds both ABSA International credentials; the Registered Biosafety Professional (RBP) and Certified Biological Safety Professional (CBSP).

Kristin King, DrPH, CBSP(ABSA), University of Texas-Houston, Houston, TX

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).

Zackary Becker, MPH, CBSP(ABSA)
UTHealth—Houston
Houston, TX

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.

Saturday, November 2, 2024, 8:00 AM – 12:00 PM

10. Introduction to Biosafety

This course is designed for individuals new to the profession, EHS professionals needing an understanding of biosafety, and for those interested in a refresher on the fundamental principles and practices of biosafety. Participants will gain a solid foundation in biosafety concepts, enabling them to understand and mitigate risks associated with biological materials in various laboratory settings. Class content and discussion include regulatory standards and guidelines, hazard identification, risk assessment and mitigation. Mitigations discussed will include biosafety levels and facility design, proper choice and use of personal protective equipment, waste management, decontamination and sterilization, and more.

Objectives:

  • Identify the breadth of duties that may be central or peripheral to a biosafety professional
  • Restate the major sources of regulatory and guidance materials available to them
  • Describe the roles others within the institution play in supporting biosafety

Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

COURSE FACULTY

Paul Meechan, PhD, RBP(ABSA), CBSP(ABSA)
Biosafety Consultant
Catonsville, MD

Paul J. Meechan is currently a biosafety consultant, providing guidance and training to a number of academic and government institutions regarding safe containment practices. He has over 30 years’ experience in the field, including positions at the CDC and Merck and Co., Inc. He was also the CDC editor for the 6th edition of the NIH/CDC manual Biosafety in Microbiological and Biomedical Laboratories. Paul has served as President of ABSA International and holds a PhD from the University of Rochester.

Scott Alderman, MS, CBSP(ABSA)
Duke University
Durham, NC

CONTACT HOURS

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.

Saturday, November 2, 2024, 8:00 AM – 12:00 PM

11. Integrating AI into Synthetic Biology: A Biosecurity Risk Assessment Course

This intensive half-day course is designed for biorisk management professionals who are at the forefront of integrating Artificial Intelligence (AI) into synthetic biology. With AI rapidly transforming scientific research and applications, its adoption presents unique biosecurity challenges. This course provides an in-depth look into the specialized biosecurity risk assessment process tailored for AI applications in synthetic biology, combining theoretical foundations with practical, hands-on exercises and interactive case studies. Some of the topics to be covered include: an overview of AI technologies and their applications in synthetic biology; fundamentals of biosecurity risk assessment for AI; discuss the concepts of vulnerability, threat, risk, consequence, and mitigation; develop a dynamic risk management plan and strategies for continuous monitoring and updating of risk assessments to address the evolving nature of AI technologies and synthetic biology applications. Attendees will also discuss the challenges of maintaining an adaptable and proactive risk management stance in a rapidly advancing scientific field.

Objectives:

  • Explain at a basic level the AI integration in synthetic biology research
  • Identify associated biosecurity risks
  • Apply a structured approach to assess these risks using newly developed tools and methodologies

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals

Audience Level: Basic

COURSE FACULTY

Leyma De Haro, PhD, RBP(ABSA)
Merrick & Company
Greenwood Village, CO

Dr. Leyma P. De Haro received a BS in Biochemistry from California State University, Los Angeles, and holds a PhD in Biomedical Sciences from the University of New Mexico. She is a Registered Biosafety Professional (RBP) by ABSA International. She completed two postdoctoral fellowships, including one at Los Alamos National Laboratory. Dr. De Haro worked at Sandia National Laboratory, in the internationally renowned Global Chemical and Biological Security Team, where she specialized in Biosafety and Biosecurity on a global scale. She is currently a Senior Scientist specializing in Biosafety and Laboratory Operations at Merrick. Dr. De Haro has over 14 years’ post PhD experience as a scientist, helping laboratories and organizations enhance their biosafety and biosecurity practices. Her background in innovative scientific research enables her to understand the unique safety challenges laboratories and organizations face in today’s rapidly evolving world of life sciences. With a keen focus on fostering a culture of responsibility and safety, Dr. De Haro is committed to promoting best practices in biosafety and biosecurity worldwide, supporting the life sciences community in pursuing groundbreaking discoveries and innovations.

CONTACT HOURS

This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.

Sunday, November 3, 2024, 8:00 AM – 5:00 PM

14. Medical Emergencies in the Laboratory – Are you prepared?

Biological Sciences form the foundation of medical research and healthcare including: biochemistry, molecular, cellular, developmental biology, microbiology, plant biology/pathology and public health. Biosafety professionals regularly train staff to handle spills, exposure to chemicals, weather related events, power outages, and biosecurity, but what about medical emergencies? Your organization may have emergency response procedures, but are the individuals in the lab, field, or even visitors prepared to handle first aid in situations involving biologicals? Personnel should be able to recognize and react to medical emergencies they may encounter at your institution involving biologicals. Early recognition of potential medical emergencies can reduce long-term or deadly consequences and legal challenges. Medical emergencies may involve only one individual or it can be a large-scale emergency. Prepare your personnel to respond appropriately in order to avoid worsening the situation. Discover ways to improve communication and cooperation with internal emergency response teams and local emergency responders (911 operators, fire, EMS, law enforcement) when biologicals are involved. Consider the impact when First Responders arrive on scene and see a BSL-2 or BSL-3 sign. If an ambulance is required, is the patient ready to transport? Although you cannot predict every emergency, preparing your personnel to think through a response by preplanning for an event and the steps to recovery is necessary to simplify an emergency response. This class will offer guidance and assistance in preparing for emergencies.

Objectives:

  • Establish relationships with local emergency response
  • Summarize the right response in a medical emergency
  • Communicate the decontamination procedures to employees and emergency responders

Suggested Background: Basic first aid
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers

Audience Level: Basic

COURSE FACULTY

Deborah Howard, MPH, CBSP(ABSA)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, BS, BASF, Durham, NC

Anita Harrell, BS
North America Biosafety Manager
BASF
Durham, NC

Anita Harrell has 10 years of experience in the fields of Occupational Safety, Biological Safety and Laboratory Safety. She has worked at BASF for 35 years and is currently the North America Biosafety Manager. Prior to joining BASF, Anita worked at North Carolina State University in Raleigh, NC. She received a degree in Botany from NCSU in 1983. Anita currently oversees the North American Biological Safety Programs. She works with site biosafety representatives to oversee these areas. She participates and several global biosafety teams at BASF.

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.

Sunday, November 3, 2024, 8:00 AM – 12:00 PM

19. The Big, Bright Beautiful World of BSL-2

In the world of biosafety, balancing risk management with potential uncertainties can be tricky. We have all heard the adage that in biosafety, “it depends”, and nowhere is this a more accurate statement than in a biosafety level 2 (BSL-2) laboratory. Unlike the clear-cut requirements of other containment levels, BSL-2 boasts a spectrum of flexibility that can be both empowering and confusing. Housing agents from Risk Group categories 1 through 3, BSL-2 laboratories can resemble the “wild west” of biosafety. While this adaptability allows tailored safety protocols, it also provides a breeding ground for uncertainty and potential for error. When does a BSL-1 space become a BSL-2 lab or BSL-2 become a BSL-3? Where do recommendations end and requirements begins? When can an RG-3 agent be handled in a BSL-2 laboratory, and why? From understanding airflow requirements and choosing the right biosafety cabinet (if you need it) to choosing crafting functional safety protocol and assessing the highly controversial BSL-2+, this course is intended for the biosafety novice to delve deeper into the ever fluid BSL-2 space and gain confidence navigating the waters where “it depends”.

Objectives:

  • Distinguish between recommendations and requirements for BSL-2 laboratories
  • Identify when RG-3 agents are handled under BSL-2 containment and when should RG-1 agents be moved to BSL-2
  • Restate how to adjust the 3 risk mitigation controls to get to meet specific biosafety needs and what is “BSL-2+”

Suggested Background: None
Target Audience New Biosafety Professionals, Laboratory Workers, Clinicians, EHS, Other safety professionals who work with biological materials

Audience Level: Basic

COURSE FACULTY

Heidi Page, MS, RBP(ABSA), SABAI Global—Shield Consulting, Chesterfield, MOHeidi Page, MS, RBP(ABSA)
SABAI Global—Shield Consulting
Chesterfield, MO

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.

Sunday, November 3, 2024, 8:00 AM – 12:00 PM

20. Implementing Field Biosafety Levels: Standardizing Safety Across Disciplines

The challenge of standardizing biosafety in field settings, especially in studies involving zoonotic disease transmission, has historically been complicated by inconsistent guidance from various institutional biosafety committees, Institutional Animal Care and Use Committees (IACUCs), and governmental agencies. This inconsistency often stems from differing levels of field experience and expertise among these groups. This course will address this gap by introducing a set of innovative Field Biosafety Levels (FBSLs) aimed at establishing uniform safety guidelines applicable to all researchers, regardless of their scientific discipline or the nature of their field work. This course will guide attendees through the critical processes of identifying primary hazards, conducting thorough risk assessments, and applying the novel FBSL framework effectively in their projects. By following a structured hierarchy of hazard controls, the FBSL framework provides the first comprehensive, risk-based guidelines designed to enhance health preparedness, enforce rigorous hygiene practices, ensure effective decontamination procedures, and manage waste efficiently. Additionally, the course will explore a tiered system of personal protective equipment (PPE) selection, tailored to varying levels of exposure and risk. Attendees will leave with a deeper understanding of how to integrate these standards into their fieldwork, resulting in improved safety outcomes and reduced risk of pathogen transmission. This course is crucial for researchers seeking to elevate the safety protocols of their field studies, providing them with the tools and knowledge to implement best practices consistently and effectively.

Objectives:

  • Identify and apply FBSLs to effectively apply standards to various types of field research
  • Apply techniques to conduct thorough risk assessments tailored to field settings
  • Implement enhanced health and safety protocols

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB), Risk Assessment, Virology/Viral Vectors
Target Audience: All Safety Professionals, Scientists conducting activities in the field

Audience Level: Basic

COURSE FACULTY

Marc Valitutto, VMD (Veterinarian)
Field Biosafety Solutions
New York, NY

Dr. Marc Valitutto is a senior field veterinarian at EcoHealth Alliance, where he focuses on pandemic preparedness throughout the world. He is involved in collaborative research investigating wildlife as a zoonotic disease reservoir, as well as identifying ways of protecting endangered species in their natural habitats. His primary focus is on animal welfare and occupational safety through the advancement of animal biosurveillance methods and developing practical biosafety solutions for field participants, respectively. He previously served as global lead for the USAID Emerging Pandemic Threats PREDICT project in Myanmar, where he and his colleagues detected novel coronaviruses in endemic bat populations. He received his Doctorate of Veterinary Medicine from the University of Pennsylvania and completed a four-year residency in zoological medicine and surgery at the Wildlife Conservation Society and Cornell University. Prior to joining EcoHealth Alliance, he served in various roles focused on animal health and conservation. His work has been featured on several media outlets, including CBS’s 60 Minutes and NBC’s Today Show.

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
Registration is closed for this webinar. You may purchase the recording.

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)

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY

Deborah Howard, MPH, CBSP(ABSA)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, BS, BASF, Durham, NC

Anita Harrell, BS
North America Biosafety Manager
BASF
Durham, NC

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, BASF, Durham, NC

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.

COURSE FEES

ABSA Members: $720 USD
Nonmembers: $820 USD

CONTACT HOURS

This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.50 P.A.C.E.® contact hours.

Friday, September 13, 2024, 11:00 AM – 3:30 PM CDT
Registration is closed for this webinar. You may purchase the recording.

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)

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY

Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Research Triangle Park, NC

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).

COURSE FEES

ABSA Members: $500 USD
Nonmembers: $600 USD

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
Registration is closed for this webinar. You may purchase the recording.

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)

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY

Patrick Conley, MS, CBSP(ABSA), NREMT
Merrick and Company
Keller, TX

COURSE FEES

ABSA Members: $500 USD
Nonmembers: $600 USD

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
Registration is closed for this webinar. You may purchase the recording.

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)

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.

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY
Susan Harper, DVM, DACLAM, DACVPM, RBP(ABSA), NIH-Office of Animal Care and Use, Bethesda, MD

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, University of Washington, Seattle, WA

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.

COURSE FEES

ABSA Members: $720 USD
Nonmembers: $820 USD

CONTACT HOURS

This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.50 P.A.C.E.® contact hours.

Wednesday, October 9 and Friday, October 11, 2024, 11:00 AM – 3:30 PM CDT
Registration is closed for this webinar. You may purchase the recording.

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)

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY

Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Research Triangle Park, NC

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).

COURSE FEES

ABSA Members: $720 USD
Nonmembers: $820 USD

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
Registration is closed for this webinar. You may purchase the recording.

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)

Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.

COURSE FACULTY

Kathryn Harris, PhD, RBP(ABSA)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: $500 USD
Nonmembers: $600 USD

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.