Professional Development Courses

All times listed are in CENTRAL TIME ZONE

Intermediate Level Courses

For those with basic knowledge or would like to learn more.

In-Person Courses
October 13-15, 2023

CHI Health Center, Omaha, Nebraska

Saturday, October 14, 2023, 8:00 AM – 5:00 PM, Room 206

4. Facilities Fundamentals for Biosafety Professionals

This course is aimed at strengthening safety at biocontainment facilities by helping biosafety professionals understand how facility operations support overall biocontainment operations. Through a mixture of presentations from experts in the field and interactive exercises, participants will reinforce their knowledge of discrete facility system function and ways individual systems complement each other holistically in operating biocontainment facilities. Participants will gain practical knowledge of related facility issues (e.g., facility design, maintenance, performance verification, and waste management) and their roles in them. 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 biosafety.

Objectives:

  • Clarify the practical knowledge gained of facility issues (e.g., design, maintenance, and performance verification) and their roles in them
  • Develop an understanding of specific infrastructure, equipment, and systems related to the operation of a biocontainment facility
  • Interpret how specific facility systems operate and support biocontainment

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals, Facilities Personnel

PDC Level: Intermediate

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), Merrick & Company, Greenwood Village, CORachel Gamble, DrPH, RBP(ABSA), CBSP(ABSA)
Associate Director of Biosafety and Biosecurity
Merrick & Company
Greenwood Village, CO

Dr. Rachel Gamble is the Associate Director, Biorisk Management Programs within Science & Technology in the Life Sciences practice at Merrick. Rachel has 15+ years of experience directing and managing safety programs for two biomedical research institutions with focused experience in biological safety and select agent regulations. She previously served as the Director of the Office for Environmental Safety as well as the director for the high containment/select agent research facility at Baylor College of Medicine. During this time, she also held faculty appointments at The University of Texas Health Science Center School of Public Health in the Epidemiology, Human Genetics, and Environmental Sciences department and Baylor College of Medicine in the Molecular, Virology, and Microbiology department. She is currently assisting with the stand-up of the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS, on behalf of the U.S. Department of Homeland Security and the U.S. Department of Agriculture in addition to various projects for government and academic institutions both domestic and international.

Rachel has been an ABSA member since 2006 and currently serves on the Training Tools and Resources Committee and the Scientific Program Committee. In addition to being an active ABSA member, she is active in her regional ABSA affiliate, the Southern Biosafety Association (SBA) and has held previous positions as the treasurer, vice president, president, and past president. Currently, Dr. Gamble is serving another term as the SBA’s vice president and a reviewer for Applied Biosafety—The Journal of ABSA International.

Aurel Tamburri, MS, CRSP(CABS)
Aurel Tamburri, MS, CRSP(CABS)
Director – Research Safety & Compliance
Univeristy of Toronto
Toronto, Ontario, Canada

Aurel Tamburri has over 25 years of progressive experience in laboratory operations, safety and support services. Since 2000, Aurel has held a number of key leadership roles with the Ontario Ministry of Health, Public Health Ontario and most recently with the University of Toronto. His area of expertise includes safety and biorisk management, laboratory operations, process design, program management and regulatory compliance. Aurel received a Master’s Degree in Health Management from Mc Master University, a graduate diploma in Occupational Health, Safety & Environmental Medicine from Mc Master University, a diploma in Medical Laboratory Science from the Michener Institute and is qualified as a Canadian Registered Safety Professional. Over the years, Aurel has managed a number of clinical and service related program areas, led a number of initiatives in process and quality improvements, transition plans and continues to build efficiencies within laboratory operations.

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 14, 2023, 8:00 AM – 5:00 PM

5. Facility Commissioning and Recommissioning for BSL-3 Laboratory

By understanding the commissioning and recommissioning processes, it can assist the biosafety professional in start-up or maintaining their laboratory operations to perform the program. Laboratory commissioning, identified in containment guidance documents, is a quality assurance process for the effective functioning of biocontainment laboratories. The biosafety officer and other decision makers benefit by having a basic understanding of the commissioning and recommissioning processes and resulting documentation. This course will review the phases of the new facility commissioning process and similar process for recommissioning. This knowledge base allows the biosafety professional to recognize how commissioning assists in providing and documenting a properly operating facility. A review of the secondary containment features of the BSL-3 laboratory will be disucssed and note specific issues typically observed. There will be a focus on two issues, the reversal of directional airflow and sealing of surfaces and penetrations. Participants will consider methods to identify the issues and present some specific mitigations of these issues; can actively participate in the commissioning/recommissioning processes and understand the methodology, the tools, results, and their interpretation; will know their facility operates correctly, its limitations, and the risk when it does not. This knowledge allows the biosafety professional to check or back check the containment spaces’ performance and use this knowledge to perform daily inspections for maintenance or replacement and control risk to the lowest level. The biosafety professional can identify required features in a new laboratory or review an existing lab with a better understanding of typical issues to assure safe reliable operations.

Objectives:

  • Develop an understanding of the overall commissioning and recommissioning processes for containment labs
  • Articulate the engineering controls required and effectively participate in the processes
  • Identify typical issues observed during commissioning/recommissioning of the laboratory secondary containment barriers and the options for practical solutions to those issues
  • Demonstrate a knowledge base and provide documentation to better perform daily inspections to reduce risk for safe and reliable laboratory operations

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Operations and Maintenance Personnel

PDC Level: Intermediate

COURSE FACULTY

Joby Evans, PE, CAC, CBCPJoby Evans, PE, CAC, CBCP
Commissioning Engineer/Technical Lead
Georgia Engineering LLC
Atlanta, GA

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.

Saturday, October 14, 2023, 8:00 AM – 5:00 PM, Room 207

6. Engineering for the Biosafety Professional Part II

Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance, and certification of their containment facilities and building systems. Frequently, the biosafety professional is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course provides basic engineering principles that are useful in the planning, design, construction, maintenance, and operation of a BSL-3 or high-containment facility. The principles are expanded to BSL-4 or maximum containment facilities for clarity between BSL-3 and BSL-4 requirements. To participate in these activities, the biosafety professional will need a foundation of engineering fundamentals, skills to ask questions in engineering terms, and the confidence to question the answers. Topics covered include interpreting architectural and engineering drawings including plan views, personnel and waste flows, scaling, calculating air changes, and an in-depth review of HVAC drawings, airflow reversal mitigation, and engineering redundancies. There will be a review of commissioning and certification processes, including elements of ventilation assessment. Individual and group exercises will be conducted for practical application of principles presented. Building on “Engineering for the Biosafety Professional – Part I,” this course will integrate examples that show cause and effect in real-life scenarios.

Objectives:

  • Discuss engineering principles
  • Apply engineering assessment tools for architectural and engineering drawings
  • Evaluate engineering solutions

Suggested Background: Fundamentals of Biosafety, Engineering for the Biosafety Profession Part 1 (preferred)
Target Audience: All Safety Professionals, New Biosafety Professionals

PDC Level: Intermediate

COURSE FACULTY

Juan Osorio, IEJuan Osorio, IE
Chief Operating Officer
World BioHazTec Corporation
Pasadena, MD

Juan Osorio provides consulting in engineering with a focus in high and maximum containment laboratories (BSL-3 and BSL-4), biomedical facilities, hospitals and research facilities. In this role, he consults with clients regarding laboratory planning, programming, commissioning, validation and third party certification activities for significant biocontainment, laboratory, vivarium, safety and healthcare projects. Mr. Osorio has consulted, reviewed, validated, and certified biocontainment laboratories, mission critical government institutions, vivaria, and world-class medical facilities. He has vast experience in the high- and maximum containment fields and participates on biocontainment projects in the United States, Asia, and South America. Mr. Osorio contributes to the design, construction, validation, third-party certification, and maintenance of such facilities. He has served frequently as a consultant for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for industrial engineering issues in biocontainment, general laboratory, hospital, and vivarium projects. He has assisted in the development of high- and maximum containment government guidelines and regulations for the NIH.

Theodore Traum PE, CCP, DGCP
Theodore Traum PE, CCP, DGCP
Principal Engineer and Board Member
World BioHazTec Corporation
Pasadena, MD

Theodore (Ted) Traum has over thirty years of experience in engineering with a focus in high- and maximum containment laboratories (BSL-3 and BSL-4), biomedical facilities, hospitals and researchfacilities. In this role, he consults with clients and oversees laboratory planning, programming, commissioning, validation, and third-party certification activities for significant biocontainment, laboratory, vivarium, safety and healthcare projects. Following the September 11, 2001 attacks, Mr. Traum received a considerable influx of biosafety and biocontainment projects to combat bioterrorism. Capitalizing on his niche expertise in this fast growing industry and its previous work with the JCAHO statement of conditions, Mr. Traum focused his business development efforts towards developing acertification program for biocontainment laboratories, their design, construction, operation, biosafety consultation, and maintenance through World BioHazTec (WBHT). Being one of the only few firms in the United States with a significant level of expertise and previous success in niche projects for the healthcare and research laboratories, Mr. Traum became sought after nationally and internationally as the premier consultant for oversight, management, and certification of biocontainment facilities. Mr. Traum has consulted, reviewed, validated, and certified biocontainment laboratories, mission critical government institutions, vivaria, and world-class medical facilities. He is a highly respected professional engineer in the high- and maximum containment field and is sought worldwide for his experienceand expertise in design, construction, third-party certification, and maintenance of such facilities. He has served frequently as a consultant for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration for HVAC, mechanical, and industrial engineering issues in biocontainment, general laboratory, hospital, and vivarium projects.

CONTACT HOURS

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

Saturday, October 14, 2023, 8:00 AM – 12:00 PM, Room 209

8. Practical Aerobiology Concepts

This course will provide biosafety professionals with an understanding of tools used to generate and sample bioaerosols. Course discussion will cover how bioaerosols are generated, common experimental aerosol generators, and factors that control number of organisms in a single particle. Subsequent material will cover sampling conditions and samplers that are appropriate to collect bioaerosols. The advantages and disadvantages of different bioaerosol generators and samplers will be discussed throughout. Practical application of bioaerosol generators and samplers will be covered both in didactic lecture and small-group activities.

Objectives:

  • Describe how bioaerosols are experimentally generated through different aerosol generators
  • Identify the factor(s) that control number of organisms contained in a single particle
  • Summarize the advantages and disadvantages of different bioaerosol samplers

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals

PDC Level: Intermediate

COURSE FACULTY

Althea Treacy, PhD, CBSP(ABSA)Althea Treacy, PhD, CBSP(ABSA)
National Institutes of Health
Bethesda, MD

Dr. Treacy is an Associate Biosafety Officer, the Quarantine Permit Service Office Team Lead, and Alternate Responsible Official (Select Agent Program) in the Division of Occupational Health and Safety at the National Institutes of Health (NIH). Her duties include providing expert safety guidance to researchers working with biological materials and recombinant nucleic acids, reviewing requests to import or export biological materials, delivering safety training to high containment researchers at NIH Bethesda, and mentoring fellows in the National Biosafety and Biocontainment Training Program (NBBTP). Dr. Treacy earned her Bachelor of Science with High Honors in Microbiology from the University of Michigan in 1998 and her PhD from Washington University in St. Louis in the Molecular Microbiology and Microbial Pathogenesis program in 2005. During her doctoral work she identified and characterized two UDP-galactose transporters in the protozoan parasite Leishmania major, refining the role of glycoconjugate synthesis in the parasite life cycle and disease pathogenesis. Dr. Treacy then did postdoctoral research at The Scripps Research Institute, La Jolla, and the University of California, Irvine, where she investigated molecular interactions required for arenaviral budding and roles for the arenaviral matrix protein in viral RNA synthesis and infection. While at UC-Irvine, she also mentored undergraduate students, taught undergraduate biological science courses, and served as BSL-3 laboratory manager. In 2014, Dr. Treacy completed a fellowship in the NBBTP at the NIH. As a NBBTP Fellow, she examined the effective life span ULPA filters in aerosol management systems for cell sorters, produced a training video to promote safer practices when using biological safety cabinets, and developed virtual lectures that were adopted as part of the American Society for Microbiology’s Culture of Responsibility workshops.

Richard Baumann, PhD, SM(NRCM)Richard Baumann, PhD, SM(NRCM)
Biological Safety Officer | Alternate Responsible Offical (Select Agent Program)
National Institutes of Health (NIH)
Bethesda, MD

Richard Baumann has been the NIH Biological Safety Officer (BSO) at the Bethesda campus for over 15 years. He is a proud member of ABSA International and an active committee participant. Rick serves as an Alternate Responsible Official (ARO) and spearheads the NIH Institutional Biosafety Committee (IBC) working within the Biorisk Management branch in the Division of Occupational Health and Safety (DOHS). The NIH IBC reviews biological and rDNA registrations from 23 of the 27 NIH Institutes involved in intramural research at the Bethesda and Baltimore campuses, and at the Integrated Research Facility in Frederick, MD. He is a mentor for specialists within the division, fellows within NIH NBBTP program, as well as medicine and science scholars outside the NIH community. Before coming to NIH, he was an assistant professor, mentor and bench researcher at the US Naval Academy, and a researcher at the US Department of Agriculture (USDA) and in the biotech industry. Rick received his BS degree in Molecular Biology at the Florida Institute of Technology, Master’s in Biochemistry at Johns Hopkins School of Health and Public Hygiene, and Ph.D. in Biochemistry and Molecular Biology at the University of Maryland, School of Medicine in Baltimore, MD. His background is in molecular biology, protein chemistry, medical research, and laboratory safety with biological agents. At the NIH, he strives to be a consistent, approachable catalyst for investigators for the safe progress of their research amidst the inevitable changes that occur within organizations, and the field of biosafety.

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 14, 2023, 8:00 AM – 12:00 PM, Room 205

9. Intersection Between Biosafety and Infection Control: An Introduction to Infection Control and Biosafety in Clinical Spaces

This course is meant for the biosafety professional who would like to learn more about application of biosafety principles in the clinical environment and partnering with Infection Control Departments in health systems. This is increasingly important as clinical trials using biological therapeutics, such as human gene transfer (HGT), require safety professionals to develop investigational product handling, preparation, and administration protocols that align with current clinical safety practices and environments. The goals of this course are to introduce different clinical environments, specific biosafety considerations for each space, hospital regulatory requirements that influence safety protocols, and how to collaborate with hospital infection control professionals to operationalize safety protocols in a way that’s meaningful to hospital staff.

Objectives:

  • Describe inpatient, procedural and outpatient clinical environments and how this affects implementation of biosafety practices
  • Restate the similarities and differences between biosafety levels, isolation precautions, and standard precautions
  • Summarize how NIH and BMBL guidelines relate to hospital regulatory and accreditation requirements when creating protocols for HGT clinical trials

Suggested Background: Principles and Practices of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals

PDC Level: Intermediate

COURSE FACULTY

Allison Reeme, PhD, CIC, RBP(ABSA)Allison Reeme, PhD, RBP(ABSA)
Shield Consulting
Chesterfield, MO

Allison Reeme has over 6 years of experience in infection prevention and hospital epidemiology at an academic medical center consisting of acute care, procedural, and outpatient care settings. She has led multiple quality improvement projects, assisted in hospital credentialing preparedness, mitigating outbreaks of multidrug-resistant organisms, and designing clinical spaces. Allison has 6 years of experience serving as a Human Gene Therapy expert (HGT) on the Institutional Biosafety Committee, supported a CAR-T cell manufacturing facility and assisted with the training and education of clinical staff supporting HGT clinical trials. Allison has 5+ years’ experience working in A/BSL-2 and A/BSL-3 laboratories conducting bench research with viral and bacterial pathogens. She is certified through the Certification Board of Infection Control and Epidemiology, is a Registered Biosafety Professional through The American Biological Safety Association and has doctoral degrees in Microbiology, Immunology & Molecular Genetics and Translational Science.

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 14, 2023, 1:00 PM – 5:00 PM NOW A VIRTUAL COURSE: Jan 23, 2024, 11:30-4pm CST

10V. Institutional Biosafety and Biosecurity – Enhancing Oversight through Effective Governance

This course will discuss the importance of ensuring institutions have robust and comprehensive biosafety and biosecurity governance structures in place. Information will be provided about Federal activities related to strengthening biosafety and biosecurity practices and oversight. Participants will discuss and share tools and best practices that institutions can employ to enhance their biosafety and biosecurity programs.Participants will break into small groups to discuss a case study involving a biosafety incident occurring at an institution subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), which illustrates the importance of institutional biosafety oversight and how inadequate local oversight can result in significant problems. Participants should ideally have a working knowledge of the roles and responsibilities of institutions, Institutional Biosafety Committees (IBCs), and Institutional Review Entities (IREs) for biosafety and biosecurity oversight of research subject to the NIH Guidelines and the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC).

Objectives:

  • Describe how to implement an effective program of biosafety and biosecurity oversight
  • Paraphrase common challenges and possible solutions
  • Identify tools and best practices that institutions can employ to strengthen their biosafety and biosecurity programs
  • Summarize the requirements for reporting incidents under the NIH Guidelines and the importance of ensuring robust and comprehensive biosafety and biosecurity governance structures are in place

Suggested Background: IBC Basics, Background knowledge of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Target Audience: All Biosafety Professionals, IBC members, research compliance staff

PDC Level: Intermediate

This webinar will be one 4-hour webinar session on Tuesday, January 23, 2024, 11:30 AM – 4:00 PM CST with a 30-minute break. For the webinar, you should plan on logging in at 11:15 am (CDT) on January 23, 2024. You are required to attend the webinar session, complete the pre-course and post course assessments, and complete the evaluation in order to receive the completion certificate through the ABSA International Training Site. The link in the invitation will be unique to the user and cannot be shared.

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.

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: $440 USD
Nonmembers: $540 USD

To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 4-hours of interactive instruction from a well-respected subject matter expert.

Confirmed, paid participants will be sent detailed information regarding the course approximately one week prior to the course. Substitutions allowed with notice by 12/26/2023. There is a 15% processing fee for cancellations prior to 12/26/2023. Cancellations between 12/26/2023 and 1/2/2024 will be refunded at 50% of the course fee. No refunds after 1/2/2024.

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 attendee list for the webinar through Zoom platform all instances of that person’s name will be removed from the webinar with no refund. The webinar and its associated links are for single, individual use only.

Saturday, October 14, 2023, 1:00 PM – 5:00 PM

11. Respiratory Protection for Biosafety Professionals

This course will provide an overview of respiratory protection personal protection equipment (PPE), including selection considerations for biological and chemical hazards. A deeper dive into key hazards relevant to biosafety professionals and their respiratory protection considerations will follow. While mostly based on U.S. OSHA Respiratory Protection Program requirements, much of theinformation presented will be applicable internationally.

Objectives:

  • Describe the basic process for hazard and exposure assessment necessary for selecting appropriate respiratory protection
  • Identify the types and styles of respiratory protection equipment, in addition to U.S. OSHA requirements for their use
  • Summarize the process of respirator selection and program implementation in their workplace for key hazards

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

PDC Level: Intermediate

COURSE FACULTY

Kathryn Thompson, MPH, MS, CIH, MT(ASCP)Kathryn Thompson, MPH, MS, CIH, MT(ASCP)
Technical Training and Education Specialist
3M
Annandale, MN

Kathryn Thompson has over 30 years of industrial hygiene experience in a variety of industrial andhealthcare applications, including infection control and technical support for disinfectant products. Kathy has been with 3M for the past 28 years and currently supports the selection and use of personal protective equipment with a focus on customers in the pharmaceutical andchemical industries. Kathy is a Certified Industrial Hygienist (CIH) and Medical Technologist MT(ASCP) with a Master of Public Health and MS in Chemistry.

CONTACT HOURS

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

Sunday, October 15, 2023, 8:00 AM – 5:00 PM, Room 206

13. Pharmaceutical Biosafety Officer Training

The course is intended for Pharma BSOs and can be a complimentary course to Principles and Practices of Biosafety (PPB) offered by ABSA. The instructors will cover key topics such as the Biorisk Management Framework, the ISO 35001 Standard that features a high-level review of the new ISO Standard and implementation examples, and the Regulatory Framework including key regulations in U.S. and non-U.S. regulations and key differences between regions. Examples from Applied Biosafety will lead to a discussion of new technology platforms in the industry to include CRISPR, alpha virus, viral vector gene therapy, human cell lines, lab acquired infections (e.g., N. meningitis, rabies large scale infection, Brucella large-scale), improper inactivation scenarios, animal blood and tissue samples, human neurological tissue concerns, environmental release of biological agents (biological agent release scenario- how handle). This course will be interactive with a variety of group exercises where participants will review P&IDs, identify issues, propose recommendations for what would be acceptable vs. not.  Also, look at HVAC, placement of equipment, types of equipment needed, room pressurization, workflow, decontamination (autoclave, HEPA, kill tanks, chemical treatment), permitting, and risk assessment completion. The course will conclude with a roundtable discussion, presentation of the group exercises, and Q&A.

Objectives:

  • Identify the global biorisk management regulatory framework applicable to pharmaceutical companies
  • Restate how to integrate biosafety principles into engineering design projects
  • Summarize how to conduct a biorisk assessment and expectations for biosafety committee approval

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals

PDC Level: Intermediate

COURSE FACULTY

Arif Peshimam, MSOH, MPH, MD, RBP(ABSA)Arif Peshimam, MSOH, MPH, MD, RBP(ABSA)
Global Head of Biosafety
Sanofi
Framingham, MA

Arif Peshimam is the Global Head of Biosafety for Sanofi, a Multinational Pharmaceutical Company. He is responsible for overall biosafety program management for manufacturing and R&D sites within the company. Prior to joining Sanofi, Arif was Corporate BSO for Southern Research, served as a Health Specialist/Industrial Hygienist in Health Safety & Environment at King Abdullah University of Science & Technology in Saudi Arabia, and was the Biosafety Officer and EHS Specialist in the Department of Environmental Health & Safety at the University of California—Riverside (UC Riverside). While at Case Western Reserve University, he implemented the Biological Safety and the Industrial Hygiene Programs from 2003 to 2008.

Arif is a Registered Biosafety Professional (RBP) with ABSA International (American Biological Safety Association) and is trained in OSHA 24-hour HAZWOPER and the National Incident Management System. He holds an MD degree from Grant Medical College in Bombay, India. He received a Master of Public Health in Environmental & Occupational Health through the Northwest Ohio Consortium for Public Health which includes Bowling Green State University and the University of Toledo. He also received a Master of Science in Occupational Health, with a major in Industrial Hygiene from the University of Toledo. He earned a master’s degree in Epidemiology and Biostatistics from Case Western Reserve University.

Elise Franklin, MS, MBA, CSP, CIH, RBP(ABSA)Elise Franklin, MS, MBA, CSP, CIH, RBP(ABSA)
Corporate Biosafety Officer
Bristol Myers Squibb
Princeton, NJ

Elise is the Corporate Biosafety Officer for Bristol Myers Squibb (BMS) and has been with BMS for 13 years. Elise is a CIH, CSP and RBP and has 30+ years in the EHS field with experience in biopharma, biotechnology, academics, heavy industry, high technology and consulting. Her focus areas are Industrial Hygiene, Biosafety, and Ergonomics. She received her B.S. from Colorado State University, her M.S. from UMass-Lowell and her MBA from Babson.

Rebecca McGirr, MSc, RBSO(CABS-ACSB), RBP(ABSA)Rebecca McGirr, MSc, RBSO(CABS-ACSB), RBP(ABSA)
Deputy Director, Biosafety and Industrial Hygiene
Sanofi
Toronto, Ontario, Canada

Becky McGirr is currently the Biosafety and Industrial Hygiene Lead for Sanofi’s Toronto site. She holds a Bachelor’s Degree in Biology and a Master’s Degree in Neuroscience from the University of Western Ontario and has a certificate in Occupational Health and Safety. For over 8 years, Becky has worked as a biosafety professional in various settings, in both Canada and the US, including in academic and hospital-based research institutes, and in the biopharmaceutical sector. In her current role, she leads the biosafety and industrial hygiene programs at Sanofi’s Toronto campus and is the site’s biological safety officer. Becky is a member of ABSA’s Distance Learning Committee and Technical and Regulatory Review Committee. She is also a member of the Public Health Agency of Canada’s Advisory Committee on Human Pathogens and Toxins (AC-HPT). Prior to her biosafety career, Becky spent more than 10 years as a Laboratory Manager for basic research laboratories in a hospital-based research institute, specializing in molecular, cell and microbiological techniques.

Leo Njongmeta, MBA, PhD, CSP, RBP(ABSA), CBSP(ABSA)Leo Njongmeta, MBA, PhD, CSP, RBP(ABSA), CBSP(ABSA)
Associate EHS Director | Global Biosafety Officer
AbbVie Inc.
North Chicago, IL

Leo Njongmeta is an Associate EHS Director and Global Biosafety Officer at Abbvie where he leads the Global R&D EHS Center of Excellence comprised of Biosafety, Vivarium Safety, Radiation Safety, Environmental Compliance and Dangerous Goods Shipping programs. His Team is responsible for providing strategic support to drive a Culture of Safety and Environmental Compliance in biomedical research, drug discovery, preclinical safety, and biologics manufacturing. Prior to a career in safety, Leo was a research scientist conducting biomedical research in the fields of immunology, animal models of infectious diseases and vaccine development. Leo possesses a B.Sc in Microbiology, an M.Sc in Molecular Biology, a Ph.D in Veterinary Science (Parasite Immunology) and an MBA in Leadership and Operations Management. Leo is currently an adjunct Assistant Clinical Professor in Environmental and Occupational Health Sciences at the University of Illinois at Chicago (UIC) School of Public Health. Leo holds board certifications in Safety (CBSP(ABSA), CSP), has been an active member of ABSA International serving in various committees which include current elected member of the ABSA Nominating Committee and leadership roles in the ABSA Pharma Biosafety Group.

CONTACT HOURS

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

Sunday, October 15, 2023, 8:00 AM – 12:00 PM, Room 213

17. Disinfection and Sterilization: Evaluation and Validation Concepts

This course will provide biosafety professionals with an understanding of the quality assurance and evaluation tests used in sterilization and disinfection. Understanding of these tests will directly benefit the selection of quality assurance tests when validating sterilization and disinfection processes and the selection of appropriate disinfectants. Factors responsible for heat resistance of endospores and D values applied to example biological indicators will be discussed. Further material will describe factors that affect disinfectant potency. Disinfectant product labels, disinfectant tests, and neutralizers will be discussed in didactic lecture and applied in small group activities.

Objectives:

  • Summarize the factors affecting disinfectant potency
  • Restate disinfectant evaluation testing
  • Connect technical data with disinfectant product label claims

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals

PDC Level: Intermediate

COURSE FACULTY

Althea Treacy, PhD, CBSP(ABSA)Althea Treacy, PhD, CBSP(ABSA)
National Institutes of Health
Bethesda, MD

Dr. Treacy is an Associate Biosafety Officer, the Quarantine Permit Service Office Team Lead, and Alternate Responsible Official (Select Agent Program) in the Division of Occupational Health and Safety at the National Institutes of Health (NIH). Her duties include providing expert safety guidance to researchers working with biological materials and recombinant nucleic acids, reviewing requests to import or export biological materials, delivering safety training to high containment researchers at NIH Bethesda, and mentoring fellows in the National Biosafety and Biocontainment Training Program (NBBTP). Dr. Treacy earned her Bachelor of Science with High Honors in Microbiology from the University of Michigan in 1998 and her PhD from Washington University in St. Louis in the Molecular Microbiology and Microbial Pathogenesis program in 2005. During her doctoral work she identified and characterized two UDP-galactose transporters in the protozoan parasite Leishmania major, refining the role of glycoconjugate synthesis in the parasite life cycle and disease pathogenesis. Dr. Treacy then did postdoctoral research at The Scripps Research Institute, La Jolla, and the University of California, Irvine, where she investigated molecular interactions required for arenaviral budding and roles for the arenaviral matrix protein in viral RNA synthesis and infection. While at UC-Irvine, she also mentored undergraduate students, taught undergraduate biological science courses, and served as BSL-3 laboratory manager. In 2014, Dr. Treacy completed a fellowship in the NBBTP at the NIH. As a NBBTP Fellow, she examined the effective life span ULPA filters in aerosol management systems for cell sorters, produced a training video to promote safer practices when using biological safety cabinets, and developed virtual lectures that were adopted as part of the American Society for Microbiology’s Culture of Responsibility workshops.

Richard Baumann, PhD, SM(NRCM)Richard Baumann, PhD, SM(NRCM)
Biological Safety Officer | Alternate Responsible Offical (Select Agent Program)
National Institutes of Health (NIH)
Bethesda, MD

Richard Baumann has been the NIH Biological Safety Officer (BSO) at the Bethesda campus for over 15 years. He is a proud member of ABSA International and an active committee participant. Rick serves as an Alternate Responsible Official (ARO) and spearheads the NIH Institutional Biosafety Committee (IBC) working within the Biorisk Management branch in the Division of Occupational Health and Safety (DOHS). The NIH IBC reviews biological and rDNA registrations from 23 of the 27 NIH Institutes involved in intramural research at the Bethesda and Baltimore campuses, and at the Integrated Research Facility in Frederick, MD. He is a mentor for specialists within the division, fellows within NIH NBBTP program, as well as medicine and science scholars outside the NIH community. Before coming to NIH, he was an assistant professor, mentor and bench researcher at the US Naval Academy, and a researcher at the US Department of Agriculture (USDA) and in the biotech industry. Rick received his BS degree in Molecular Biology at the Florida Institute of Technology, Master’s in Biochemistry at Johns Hopkins School of Health and Public Hygiene, and Ph.D. in Biochemistry and Molecular Biology at the University of Maryland, School of Medicine in Baltimore, MD. His background is in molecular biology, protein chemistry, medical research, and laboratory safety with biological agents. At the NIH, he strives to be a consistent, approachable catalyst for investigators for the safe progress of their research amidst the inevitable changes that occur within organizations, and the field of biosafety.

CONTACT HOURS

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

Sunday, October 15, 2023, 1:00 PM – 5:00 PM, Room 213

19. Using the Past to Prevent Future Laboratory-Acquired Infections

Preventing laboratory-acquired infections (LAIs) is a challenge for laboratory managers and biosafety professionals, especially when dealing with an emerging pathogen. It is extremely important to quickly determine if there has been an exposure, what steps need to happen next, including any prophylaxis, root cause analysis, gaps in the biosafety plan, and additional mitigation measures that need to be implemented. This interactive course will demonstrate how real-life scenarios from the ABSA LAI Database can be used as a learning and training tool to help prevent future incidents and LAIs. This course will provide an overview of how to search the LAI database and a review of two published case studies. Participants will be shown how to use an exposure assessment tool and clinical laboratory biological exposure monitoring guide (both provided) to demonstrate that the database scenarios had resulted in an exposure. Participants will be shown how to perform a root cause analysis, apply this information to find the biosafety plan gaps, and determine what additional steps are needed to mitigate the risks. In a group discussion, participants will receive new scenarios from the database; utilize the exposure assessment tool to complete the process that was illustrated from exposure determination to performing the root cause analysis, identifying the gaps, and mitigation steps to help prevent this from happening again. Additionaly, participants will learn how to use published LAI data and these tools to determine how to safely work with an emerging pathogen.

Objectives:

  • Describe how the ABSA LAI database can be used for biosafety training and determining how to safely work with emerging pathogens
  • Utilize an exposure assessment tool to assess real-life laboratory incidents for potential exposures and to help guide prophylaxis if indicated
  • Analyze actual laboratory incidents to determine the root cause and what steps are necessary to mitigate future incidents

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience All Safety Professionals, Laboratory Workers

PDC Level: Intermediate

COURSE FACULTY

Michael Pentella, PhD, D(ABMM)Michael Pentella, PhD, D(ABMM)
Clinical Professor | Director
State Hygienic Laboratory—University of Iowa
Iowa City, IA

Dr. Michael Pentella is a Clinical Professor at the University of Iowa, College of Public Health and Director of the Iowa State Hygienic Laboratory. His experience spans over forty years in clinical microbiology and public health laboratories. He is certified as an American Board of Medical Microbiology Diplomate, a specialist in microbiology through the American Society for Clinical Pathology, and certified in infection control through the Association of Professionals in Infection Control. Dr. Pentella is a member of the Association of Public Health Laboratories (APHL) Biosafety Committee, Antibiotic Resistance Lab Workgroup, the APHL Infectious Disease Committee, and the APHL Respiratory Viruses Subcommittee. He has made several contributions that have improved the practice of clinical microbiology and biosafety. He has written over 50 articles and twenty book chapters.

Shoolah Escott, MS, MT(ASCP)
Biosafety/Biosecurity Trainer & Consultant
Lexington, MA

Shoolah Escott is currently an independent, Biosafety, Biosecurity, and Bioterrorism Preparedness Trainer and a COVID-19 Contact Tracer with Partners In Health. She was the Biosafety Manager and ARO at the MA State Public Health Laboratory for over 2 years where she provided biosafety training and support to over 50 clinical laboratories and to internal public health laboratory staff. She worked for APHL/CDC National Laboratory Training Network, CDC Laboratory Training Branch for over 17 years developing, implementing, delivering, and presenting national training programs in biosafety, biosecurity and bioterrorism preparedness. She has a strong background in clinical microbiology and was the safety officer for the Memorial Hospital clinical laboratory. Currently, she serves on several ABSA and APHL committees. Here are a few key biosafety accomplishments: What Constitutes an Effective Biosafety Plan at the World Microbe Forum; Biosafety and Biosecurity: Minimizing the Risks in the Laboratory and Clinical Laboratory Biosafety Risk Assessment seminars presented nationally multiple times; and the lead on the initial development and revision of the Clinical Laboratory Preparedness and Response Guide.

Erin Bowles, BS, MT(ASCP)Erin Bowles, BS, MT(ASCP)
Laboratory Network Coordinator
Wisconsin State Laboratory of Hygiene
Madison, WI

Erin Bowles is the Laboratory Network Coordinator for the Wisconsin State Laboratory of Hygiene’s Communicable Disease Division, where she provides outreach and education to more than 125 laboratories in Wisconsin in order to ensure a coordinated statewide response to any biological threats of public health importance. Her background in clinical microbiology and expertise in biosafety serve her well as a member of APHL’s Workforce Development Committee, the Sentinel Laboratory Outreach and Partnership Subcommittee, and the Sentinel Laboratory Training Special Interest Group. Some of the committee projects that she has contributed to are revisions to the ASM Sentinel Level Clinical Laboratory Guidelines and the development of risk assessment training and biosafety tools such as the “Clinical Laboratory Preparedness and Response Guide”.

Michael Perry, MS EdMichael Perry, MS Ed
Associate Director of the Biodefense Laboratory | Alternate Responsible Official
New York State Department of Health—Wadsworth Center
Albany, NY

Michael Perry is the associate director of the Biodefense Laboratory at the New York State Department of Health – Wadsworth Center. As the ARO, APHL Biosafety and Biosecurity committee member and a member of the Wadsworth Center institutional biosafety committee, Michael has extensive training and expertise in biosafety. As part of the Global Health Security Agenda, Michael was the lead trainer for APHL’s Global Health program, developing and providing trainings in the proper use, operation, and maintenance of biological safety cabinets and biorisk management for international public health laboratorians in Africa. Over the last 10 years, Michael has conducted numerous sentinel laboratory site visit which focused on the evaluation of both laboratory biosafety which a focus on assistance with risk assessments and risk mitigation strategies.

CONTACT HOURS

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

Intermediate Virtual Courses

August 29 – November 13

(Although these courses are a part of the 66th Annual Biosafety and Biosecurity Hybrid Conference it is not necessary to attend the conference to register for these webinars.)

Tuesday, September 19 and Thursday, September 21, 2023, 11:30 AM – 4:00 PM CDT

3V. When & Why Does Biosafety Need a Seat at the Plant Research Design Table?

Plant Biosafety is a niche within the biosafety community. How to build and maintain a greenhouse, arthropod  and seed processing program can be challenging for biosafety managers because there have not been many courses offered on this topic. This class offers the basics from head house to pathogen/arthropod containment greenhouse design. Plant research is the backbone of both genetically modified, disease resistance, growth enhancement, seed health and breeding of both academic and biotechnology research. Plant biosafety is a niche within biosafety that makes you ask – Do the engineers and project managers understand the need for and when to ask for biosafety input? This course will provide participants with an overview of designing greenhouses from headhouse, seed activities to arthropod containment using the APHIS and ACL containment guidelines. The course will offer a variety of advanced scenarios and interactive exercises that demonstrate the range of biological and other risks routinely encountered in plant research. Participants 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, arthropod and seed operations.

Objectives:

  • Restate the established APHIS, ACL containment guidelines, and the established APHIS containment guidelines
  • Review and implement guidelines, hazard identification, and risk assessment techniques as they apply to plant, arthropod, and seed research
  • Report and communicate biosafety requirements to site engineers and project managers

Suggested Background: None
Target Audience: Experienced Biosafety Professionals, Laboratory Workers, All Safety Professionals, Insectary Personnel
Audience Level: Intermediate
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.

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.

Registration for this course is now closed. The recording of this webinar is available for purchase until December 19, 2023.

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: $690 USD
Nonmembers: $790 USD

To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 8-hours of interactive instruction from a well-respected subject matter experts.

Monday, October 2 and Thursday, October 5, 2023, 11:30 AM – 4:00 PM CDT

5V. Keeping it Going: Maintaining and Improving a Select Agent Program over the Long Term

Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class participants during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.

Objectives:

  • Identify strategies for efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements, including anticipating areas of emphasis in future inspections and/or future regulatory changes
  • Identify strategies for preparing for and responding to regulatory inspections, including strategies to efficiently implement necessary changes.
  • Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns in accompanying exercises
  • Summarize inactivation requirements and identify successful strategies for compliance

Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
Audience Level: Intermediate
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.

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.

Registration for this course is now closed. The recording of this webinar is available for purchase until January 2, 2024.

COURSE FACULTY
Amy Vogler, PhD, RBP(ABSA), Northern Arizona University, Flagstaff, AZ

Amy Vogler, PhD, RBP(ABSA)
Associate Director – Pathogen and Microbiome Institute
Northern Arizona University
Flagstaff, AZ

Amy Vogler is an Associate Director at the Pathogen and Microbiome Institute (PMI) at Northern Arizona University (NAU). She has worked at PMI since 1997 as a researcher and has been responsible for managing their BSL-3 Select Agent laboratory since 2009. She received her B.S. in Microbiology and Chemistry in 1999 and her Ph.D. in Biology in 2003 from NAU and is an author on 45 publications in the field of population genetics and molecular epidemiology of bacterial pathogens. She continues to conduct research on Yersinia pestis while also managing the BSL-3 laboratory. She received her RBP in 2012.

Shelley Jones, MS, RBP(ABSA), Northern Arizona University, Flagstaff, AZ

Shelley Jones, MS, RBP(ABSA)
Director of Biological Safety | Responsible Offical
Northern Arizona University
Flagstaff, AZ

Shelley Jones is the Director of Biological Safety and Responsible Official at Northern Arizona University. She received her B.S. from Illinois State University and her M.S. from Arizona State University, both in environmental disciplines. Shelley has over 30 years of diverse experience in environmental health and safety. She has been a Responsible Official/Alternate Responsible Official for 19 years.

COURSE FEES

ABSA Members: $690 USD
Nonmembers: $790 USD

To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 8-hours of interactive instruction from a well-respected subject matter experts.

Monday, November 13 and Wednesday, November 15, 2023, 10:00 AM – 2:30 PM CST

7V. Laboratory Facility Programming and Design Best Practices

This course will offer guidance of key principles underlying the programming and design of research and diagnostics laboratories. It is intended for architects, designers, and biosafety professionals desiring an increased awareness of the complexity and challenges associated with designing a laboratory. Participants will be introduced to the laboratory design process as it relates to programming and pre-design, building zoning, operational efficiency, biosafety and biosecurity considerations, and flexible/expandable strategies. Participants will participate in guided discussions, develop diagrams to illustrate best practice concepts, and analyze existing plans with respect to the design principles under discussion.

Objectives:

  • Summarize the critical information that must be gathered prior to the development of a laboratory facility design
  • Describe how to assemble and synthesize pre-design information appropriate to the development of a laboratory facility
  • Paraphrase the principles of good laboratory design, and methods for developing, analyzing, and improving them

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, Managers of design projects
Audience Level: Intermediate
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.

CONTACT HOURS

This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.

Registration for this course is now closed. The recording of this webinar is available for purchase until February 13, 2024.

COURSE FACULTY

Vibeke Halkjaer Knudsen, PhDVibeke Halkjaer–Knudsen, PhD
Vipsit LLC
Helsinge, Denmark

Vibeke Halkjaer-Knudsen (Vips) is a Senior Subject Matter Expert (SME) in areas related to biological and chemical risk management, incident management and response, accident and incident root cause investigations, dual-use materials, and high containment lab design. She performs multidimensional impact and risk assessments from a product, GMP, GMO, environment, health and safety, emergency preparedness, animal welfare, chemical and biological point of view. She has extensive experience with lab design and sustainable solutions on all continents. She sits in several think tanks and advisory boards, revises guidelines when needed and has a true passion for building the next generation of biorisk management professionals. She serves several of these younger individuals as a mentor, coach and provides reach back capacity when the daily tasks become too challenging. For almost 20 years, she was a Director at the Danish Statens Serum Institute, responsible for quality control labs, Tuberculin production, large scale vaccine production and facility design. She has spent the last 12 years at Sandia National Laboratories in New Mexico as Principal and later Distinguished Member of Technical Staff, working with international stakeholders, within the biorisk management non-proliferation programs funded by the U.S. Government. Since 2006, she has been consulting as a private GMP and Biorisk Management Consultant on the side while continuing to work her daytime jobs. In the autumn of 2022, she decided to focus full time on her role as an experienced project manager, supporting clients who were implementing biorisk management standards in their labs and in making risk informed decisions for sustainable laboratory design around the globe. She earned her PhD in Chemistry from the University of Copenhagen.

Natasha Griffith, MS, MPH, RBP(ABSA)Natasha Griffith, MS, MPH, RBP(ABSA)
Associate Director – High Containment Core
Georgia State Universtiy
Atlanta GA

Natasha Griffith is the Associate Director, High Containment Core at Georgia State University (GSU) where she oversees design and construction of new high containment research facilities and leads a multidisciplinary team to support safe operations and maintenance (O&M) of all high containment facilities at GSU. Natasha earned her Master of Science degree in Microbial Pathogenesis and a Bachelor of Science degree in Microbiology, Immunology and Molecular Genetics from UCLA as well as Master of Public Health in Paris, France. With over 15 years of experience, Natasha has led numerous international missions in response to infectious disease outbreaks.Before joining GSU, Natasha was the Branch Chief of Quality and Safety Systems, DLS, CSELS at the CDC where she led quality and safety staff to support the development of standards, guidelines, recommendations, and tools for improved quality and safety in clinical and public health laboratories. Prior to her work at CDC, Natasha directed all high contaminant facilities at the University of California, Los Angeles (UCLA).

William Arndt, PhDWilliam Arndt, PhD
Senior Biosafety Officer
Georgia State University
Atlanta, GA

William (Bill) Arndt is Senior Biosafety Officer (BSO) at Georgia State University where he oversees biosafety and biosecurity for the GSU research community and leads a multidisciplinary team to support safe research at GSU. Bill earned his Doctor of Philosophy (PhD) degree in Microbiology from Arizona State University and a Bachelor of Science degree in Microbiology from South Dakota State University. Bill is virologist by training and subject matter expert in areas of disease surveillance, infectious disease diagnostics, incident/outbreak response, vaccine development/production, high-containment laboratory operations, biorisk management, and dual-use research of concern (DURC). He has supported the US Government health security and capacity building initiatives for 12+ years across Africa, Middle East, and Southeast Asia. Before joining GSU, Bill was a Biosafety Team Lead and International Program Lead in the Division of Laboratory Systems (DLS), CSELS at the CDC where he was responsible for managing multi-member teams and projects related to providing support to public health and clinical laboratories and development of national biosafety and biosecurity legislation, policies, regulations, and guidelines development. Prior to his work at CDC, Bill was a Principal Member of the Technical Staff at Sandia national Laboratories where he led various activities related to laboratory design best practices and outbreak response.

COURSE FEES

ABSA Members: $690 USD
Nonmembers: $790 USD

To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 8-hours of interactive instruction from a well-respected subject matter experts.