Starts in:
Intermediate Level Courses
For those with basic knowledge or would like to learn more.
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
4. Intersection Between Biosafety and Infection Control: An Introduction to Infection Control and Biosafety in Clinical Spaces
This course is meant for the biosafety professional who would like to learn more about application of biosafety principles in the clinical environment and partnering with Infection Control Departments in health systems. This is increasingly important as clinical trials using biological therapeutics, such as human gene transfer (HGT), require safety professionals to develop investigational product handling, preparation, and administration protocols that align with current clinical safety practices and environments. The goals of this course are to introduce different clinical environments, specific biosafety considerations for each space, hospital regulatory requirements that influence safety protocols, and how to collaborate with hospital infection control professionals to operationalize safety protocols in a way that’s meaningful to hospital staff.
Objectives:
- Describe inpatient, procedural and outpatient clinical environments and how this affects implementation of Biosafety Practices
- Restate the similarities and differences between biosafety levels, isolation precautions and standard precautions
- Summarize how NIH and BMBL guidelines relate to hospital regulatory and accreditation requirements when creating protocols for HGT clinical trials
Suggested Background: Principles and Practices of Biosafety® (PPB), Risk Assessment
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
Allison Reeme, PhD, RBP(ABSA)
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 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 8:00 AM – 5:00 PM
7. Engineering for the Biosafety Professional Part I
Biosafety professionals (BSOs) need to be involved and knowledgeable in the operation, maintenance, and certification of their biocontainment facilities and building systems. The BSO is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course provides basic engineering principles that are useful in the planning, design, and operation of a BSL-3 facility and is intended to fill the gap by providing basic knowledge for understanding the processes used in the planning, design, construction, maintenance, and operation of a BSL-3 laboratory. For the BSO to participate in these activities, they need to understand engineering fundamentals, develop skills to ask questions in engineering terms, and possess the confidence to question the answers. This is the first course of a two-part series offered in alternating years. Part I of the course will provide information relevant to BSL-3 facilities for the determination of air change rates, define HVAC containment boundaries, interpret design drawings, understand HEPA filtration, provide an introduction to determining room heat loads and ventilation rates, provide concepts in directional airflow and room pressure differentials as well as an introduction to HVAC components. There will be presentations on planning, design (with a checklist), construction oversight, commissioning, certification/validation/ANSI Z9.14 Standard, maintenance, and operations. Upon course conclusion, the attendees should have the knowledge to better understand engineering issues in the planning, design, construction, commissioning, certification/validation, and post-occupancy of biocontainment facilities, be able to formulate informed questions, be able to interact with maintenance personnel and integrate facility operations with the biosafety program.
Objectives:
- Discuss engineering principles and the design and construction process of a BSL-3 laboratory
- Recall the phases and the strategies of a BSL-3 laboratory design
- Identify potential problems before construction begins
- Describe the elements of a quality assurance program
Suggested Background: None
Target Audience: All Biosafety Professionals, Operations and Maintenance Staff
Audience Level: Intermediate
COURSE FACULTY
Juan Osorio, 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
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, November 2, 2024, 8:00 AM – 5:00 PM
8. Keeping it Going: Maintaining and Improving a Select Agent Program Over the Long Term
Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class attendees during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to attendees’ individual programs and providing a platform to capitalize on attendees’ collective experience.
Objectives:
- Identify strategies for efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements, including anticipating areas of emphasis in future inspections and/or future regulatory changes
- Indentify strategies for preparing for and responding to regulatory inspections, including strategies to efficiently implement necessary changes
- Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns
- Summarize inactivation requirements and identify successful strategies for compliance
Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
Audience Level: Intermediate
COURSE FACULTY
Amy Vogler, PhD, RBP(ABSA)
Associate Director – Pathogen and Microbiome Institute
Northern Arizona University
Flagstaff, AZ
Amy Vogler is an Associate Director at the Pathogen and Microbiome Institute (PMI) at Northern Arizona University (NAU). She has worked at PMI since 1997 as a researcher and has been responsible for managing their BSL-3 Select Agent laboratory since 2009. She received her B.S. in Microbiology and Chemistry in 1999 and her Ph.D. in Biology in 2003 from NAU and is an author on 45 publications in the field of population genetics and molecular epidemiology of bacterial pathogens. She continues to conduct research on Yersinia pestis while also managing the BSL-3 laboratory. She received her RBP in 2012.
Shelley Jones, MS, RBP(ABSA)
Director of Biological Safety | Responsible Offical
Northern Arizona University
Flagstaff, AZ
Shelley Jones is the Director of Biological Safety and Responsible Official at Northern Arizona University. She received her B.S. from Illinois State University and her M.S. from Arizona State University, both in environmental disciplines. Shelley has over 30 years of diverse experience in environmental health and safety. She has been a Responsible Official/Alternate Responsible Official for 19 years.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 1:00 pm – 5:00 pm
12. Respiratory Protection for Biosafety Professionals
This course will provide an overview of respiratory protection personal protection equipment (PPE), including selection considerations for biological and chemical hazards. A deeper dive into key hazards relevant to biosafety professionals and their respiratory protection considerations will follow. While mostly based on U.S. OSHA Respiratory Protection Program requirements, much of theinformation presented will be applicable internationally.
Objectives:
- Describe the basic process for hazard and exposure assessment necessary for selecting appropriate respiratory protection equipment
- Identify the types and styles of respiratory protection equipment, in addition to U.S. OSHA requirements for their use
- Summarize the process of respirator selection and product implementation in their workplace for key hazards
Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals
Audience Level: Intermediate
COURSE FACULTY
Kathryn Thompson, MPH, MS, CIH, MT(ASCP)
Technical Training and Education Specialist
3M
Annandale, MN
Kathryn Thompson has over 30 years of industrial hygiene experience in a variety of industrial andhealthcare applications, including infection control and technical support for disinfectant products. Kathy has been with 3M for the past 28 years and currently supports the selection and use of personal protective equipment with a focus on customers in the pharmaceutical andchemical industries. Kathy is a Certified Industrial Hygienist (CIH) and Medical Technologist MT(ASCP) with a Master of Public Health and MS in Chemistry.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.
Saturday, November 2, 2024, 1:00 PM – 5:00 PM
13. Field Research Safety for Biosafety Professionals
Biosafety professionals are often tasked with reviewing field research protocols, but many biosafety professionals have never received training in field research safety. In this course, attendees will review hazards inherent to fieldwork, lessons learned from past incidents, and assess risk for a variety of field projects. The attendees will discuss safe work practices in the field and exposure control approaches for zoonotic, vector-borne, soil-borne, and water-borne diseases. The course will also assist attendees to identify potential gaps in institutional and regulatory oversight and steps to improve a culture of safety and preparedness in the field.
Objectives:
- Review common environmental hazards; zoonotic, vector-borne, soil-borne, and water-borne diseases relevant to outdoor or remote fieldwork
- Evaluate risk tolerance as it relates to protocol and research review
- Assess risk for a variety of field projects including wildlife research, community health studies, excavating soil, plant surveys, etc.
- Identify reasonable controls and expectations
- Describe the compliance drivers, model field safety programs, written field safety plan templates; as well as best practices, technical references and potential actions to improve culture of safety and preparedness in the field
Suggested Background: None
Target Audience: All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
15. Pharmaceutical Biosafety Officer Training
The course is intended for Pharma Biosafety Officers (BSOs), BSOs with interest in the biopharmaceutical industry, and can be a complimentary course to Principles and Practices of Biosafety® (PPB) offered by ABSA International. The instructors will review the Biosafety Regulatory Frameworks including key regulations in the U.S. and non-US regulations and key differences between regions. This includes an Introduction to the Biorisk Management Framework and the new ISO Standard. Key topics on Applied Biosafety, including examples of new technologies in industry (e.g., CRISPR, viral vector gene therapy, others), will be discussed as well as a review of the hazard classification of human cell lines, animal blood and tissue samples, a discussion on examples of LAIs (e.g., N. meningitis, rabies), improper inactivation scenarios, and environmental release of biological agents (including a biological agent release scenario—how to handle). Good Manufacturing Practices (GMP) will be discussed including what it is, why it is important, and how to harmonize GMP and biosafety requirements. This interactive course will feature a variety of group exercises where attendees will review engineering design requirements, P&IDs, identify issues, propose recommendations for what is acceptable vs. not, HVAC design, placement and type of equipment, room pressurization, workflow, decontamination (e.g., autoclave, HEPA, kill tanks), process equipment containment. A risk assessment course will be featured as part of the group exercises where attendees will discuss how to complete a risk assessment with certain perameters, then each groups risk assessment will run through an approval process (e.g., IBC) with other groups acting as the IBC and collectively review each other’s risk assessment. The course will conclude with roundtable discussions including the group scenarious, discussions, and further Q&A.
Objectives:
- Identify the global biorisk management regulatory frameworks as applicable to pharmaceutical companies
- Restate how to harmonize GMP and biosafety, and how to integrate biosafety principles into engineering design projects (including lab and large-scale)
- Summarize how to conduct a biorisk assessment and expectations for biosafety committee approval
Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101, Principles and Practices of Biosafety® (PPB), Risk Assessment
Target Audience: All Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
Rebecca McGirr, MSc, RBSO(CABS-ACSB), RBP(ABSA)
Deputy Director, Biosafety and Industrial Hygiene
Sanofi
Toronto, Ontario, Canada
Becky McGirr is currently the Biosafety and Industrial Hygiene Lead for Sanofi’s Toronto site. She holds a Bachelor’s Degree in Biology and a Master’s Degree in Neuroscience from the University of Western Ontario and has a certificate in Occupational Health and Safety. For over 8 years, Becky has worked as a biosafety professional in various settings, in both Canada and the US, including in academic and hospital-based research institutes, and in the biopharmaceutical sector. In her current role, she leads the biosafety and industrial hygiene programs at Sanofi’s Toronto campus and is the site’s biological safety officer. Becky is a member of ABSA’s Distance Learning Committee and Technical and Regulatory Review Committee. She is also a member of the Public Health Agency of Canada’s Advisory Committee on Human Pathogens and Toxins (AC-HPT). Prior to her biosafety career, Becky spent more than 10 years as a Laboratory Manager for basic research laboratories in a hospital-based research institute, specializing in molecular, cell and microbiological techniques.
Leo Njongmeta, MBA, PhD, CSP, RBP(ABSA), CBSP(ABSA)
Associate EHS Director | Global Biosafety Officer
AbbVie Inc.
North Chicago, IL
Leo Njongmeta is an Associate EHS Director and Global Biosafety Officer at Abbvie where he leads the Global R&D EHS Center of Excellence comprised of Biosafety, Vivarium Safety, Radiation Safety, Environmental Compliance and Dangerous Goods Shipping programs. His Team is responsible for providing strategic support to drive a Culture of Safety and Environmental Compliance in biomedical research, drug discovery, preclinical safety, and biologics manufacturing. Prior to a career in safety, Leo was a research scientist conducting biomedical research in the fields of immunology, animal models of infectious diseases and vaccine development. Leo possesses a B.Sc in Microbiology, an M.Sc in Molecular Biology, a Ph.D in Veterinary Science (Parasite Immunology) and an MBA in Leadership and Operations Management. Leo is currently an adjunct Assistant Clinical Professor in Environmental and Occupational Health Sciences at the University of Illinois at Chicago (UIC) School of Public Health. Leo holds board certifications in Safety (CBSP(ABSA), CSP), has been an active member of ABSA International serving in various committees which include current elected member of the ABSA Nominating Committee and leadership roles in the ABSA Pharma Biosafety Group.
Elise Franklin, MS, MBA, CSP, CIH, RBP(ABSA)
Corporate Biosafety Officer
Bristol Myers Squibb
Princeton, NJ
Elise is the Corporate Biosafety Officer for Bristol Myers Squibb (BMS) and has been with BMS for 13 years. Elise is a CIH, CSP and RBP and has 30+ years in the EHS field with experience in biopharma, biotechnology, academics, heavy industry, high technology and consulting. Her focus areas are Industrial Hygiene, Biosafety, and Ergonomics. She received her B.S. from Colorado State University, her M.S. from UMass-Lowell and her MBA from Babson.
Arif Peshimam, MSOH, MPH, MD, RBP(ABSA)
Global Head of Biosafety
Sanofi
Framingham, MA
Arif Peshimam is the Global Head of Biosafety for Sanofi, a Multinational Pharmaceutical Company. He is responsible for overall biosafety program management for manufacturing and R&D sites within the company. Prior to joining Sanofi, Arif was Corporate BSO for Southern Research, served as a Health Specialist/Industrial Hygienist in Health Safety & Environment at King Abdullah University of Science & Technology in Saudi Arabia, and was the Biosafety Officer and EHS Specialist in the Department of Environmental Health & Safety at the University of California—Riverside (UC Riverside). While at Case Western Reserve University, he implemented the Biological Safety and the Industrial Hygiene Programs from 2003 to 2008.
Arif is a Registered Biosafety Professional (RBP) with ABSA International (American Biological Safety Association) and is trained in OSHA 24-hour HAZWOPER and the National Incident Management System. He holds an MD degree from Grant Medical College in Bombay, India. He received a Master of Public Health in Environmental & Occupational Health through the Northwest Ohio Consortium for Public Health which includes Bowling Green State University and the University of Toledo. He also received a Master of Science in Occupational Health, with a major in Industrial Hygiene from the University of Toledo. He earned a master’s degree in Epidemiology and Biostatistics from Case Western Reserve University.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
16. Commissioning and Recommissioning for BSL-3 Containment Laboratory
By understanding the commissioning and recommissioning processes, it can assist the biosafety professional in start-up or maintaining their laboratory operations to perform the program. Laboratory commissioning, identified in containment guidance documents, is a quality assurance process for the effective functioning of biocontainment laboratories. The biosafety officer and other decision makers benefit by having a basic understanding of the commissioning and recommissioning processes and resulting documentation. This course will review the phases of the new facility commissioning process and similar process for recommissioning. This knowledge base allows the biosafety professional to recognize how commissioning assists in providing and documenting a properly operating facility. A review of the secondary containment features of the BSL-3 laboratory will be disucssed and note specific issues typically observed. There will be a focus on two issues, the reversal of directional airflow and sealing of surfaces and penetrations. Participants will consider methods to identify the issues and present some specific mitigations of these issues; can actively participate in the commissioning/recommissioning processes and understand the methodology, the tools, results, and their interpretation; will know their facility operates correctly, its limitations, and the risk when it does not. This knowledge allows the biosafety professional to check or back check the containment spaces’ performance and use this knowledge to perform daily inspections for maintenance or replacement and control risk to the lowest level. The biosafety professional can identify required features in a new laboratory or review an existing lab with a better understanding of typical issues to assure safe reliable operations.
Objectives:
- Develop an understanding of the overall commissioning and recommissioning processes for containment labs
- Articulate the engineering controls required and effectively participate in the processes
- Identify typical issues observed during commissioning/recommissioning of the laboratory secondary containment barriers and the options for practical solutions to those issues
- Demonstrate a knowledge base and provide documentation to better perform daily inspections to reduce risk for safe and reliable laboratory operations
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Operations and Maintenance Personnel
Audience Level: Intermediate
COURSE FACULTY
Joby Evans, PE, CSCP, CACU
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.
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
17. Strategies for Designing and Implementing a Culture of Safety
As biosafety professionals, we all desire to foster a culture of safety and responsible conduct at our institutions. We often have a clear vision of how this culture should look and feel, but how do you move from the current organizational culture to the one you desire? This course will define organizational culture; understand how culture forms; and identify artifacts, espoused values, and shared beliefs that can be used to describe an organization’s culture. Attendees will use these definitions to identify attributes of their own organization’s culture that support or block a culture of safety and responsibility. Unfortunately, most change efforts in organizations fail. Changing existing culture is difficult and can take many years. However, several change management models can be employed to develop a roadmap for effecting change. Participants in this course will learn about the Lewin and Kotter change management models and their application. Participants will apply these models to case studies of organizational change to understand how they can be leveraged at their own organizations.
Objectives:
- Describe what organizational culture is, how to identify and define it, and how it forms
- Identify attributes of an organization’s culture that block or enable safety programs
- Apply change management models such as Lewin and Kotter models to effect organizational change
Suggested Background: None
Target Audience: All Safety Professionals, Experienced Biosafety Professionals
Audience Level: Intermediate
COURSE FACULTY
Meghan Seltzer is a Lead Technical Assessor with The MITRE Corporation. She earned a bachelor’s degree in Biochemistry and Molecular Biology from the Pennsylvania State University, a doctorate in Cellular and Molecular Medicine from Johns Hopkins University School of Medicine, and a master’s degree in Management, Strategy, and Leadership from Michigan State University. Meghan is a Registered Biosafety Professional and began her biosafety career as a fellow in the National Biosafety and Biocontainment Training Program. After completing her fellowship, she worked at HHMI’s Janelia Research Campus as a manager in the Safety, Health, and Security department. During her tenure at HHMI, she was responsible for biosafety and occupational health programs as well as various research compliance efforts including IACUC, CLIA, dangerous goods shipping, import/export compliance, IRB, and IBC. Meghan is active in ABSA and ChABSA where she has served on numerous committees and council for both organizations.
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, 1:00 PM – 5:00 PM
21. Lessons Learned to Improve Biosafety
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, how many may have been exposed, 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 examine published papers from the ABSA LAI Database on laboratory acquired infections and exposures to determine what we can learn to prevent future exposures. Attendees will thoroughly examine the literature on the history of lab-acquired infections, review specific published articles, utilize the Association of Public Health Laboratories (APHL) ‘Laboratory Exposure Assessment and Symptom Monitoring Guide’ (exposure assessment tool) to assess exposures, analyze data to identify root causes of exposures, discuss identified gaps, and establish additional steps required to mitigate risks. Afterwards, attendees will divide into groups and receive new scenarios from the database. Using the APHL exposure assessment tool, they will apply the process demonstrated earlier—from determining exposure to conducting root cause analysis, identifying gaps, and proposing mitigation steps to prevent recurrence. Attendees will then learn to utilize published data on lab-acquired infections and these tools to safely handle emerging pathogens.
Objectives:
- Describe how the ABSA LAI database can be used for biosafety training and determining how to safely work with emerging pathogens
- Utilize the APHL 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
Target Audience: All Safety Professionals, Laboratory Workers
Audience Level: Intermediate
COURSE FACULTY
Michael Pentella, PhD, SM(ASCP), CIC, D(ABMM)
State Hygienic Laboratory at the University of Iowa
Coralville, IA
Dr. 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 APHL Biosafety and Biosecurity Committee, Antibiotic Resistance Lab Workgroup, the Infectious Disease Committee, and the 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.
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”.
Shoolah Escott, MS(MLS), MT(ASCP)
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.
Michael Perry, MS, 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.
Sunday, November 3, 2024, 1:00 PM – 5:00 PM
22. Navigating Regulatory Audits in Biosafety: Strategies for Success
In biosafety, regulatory compliance is paramount to ensure the safe handling of biological materials and maintain the integrity of research and healthcare activities. This course is designed to equip biosafety professionals, laboratory managers, and clinical research personnel with the knowledge and strategies to prepare for and successfully navigate regulatory audits. The course, filled with practical and applicable content, will cover critical regulatory frameworks relevant to biosafety, including those outlined by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Occupational Safety and Health Administration (OSHA). Attendees will gain insights into audit preparation techniques, documentation requirements, and best practices for ensuring compliance with regulatory standards. Through interactive discussions, case studies, and mock audit scenarios, attendees will learn how to identify potential audit pitfalls, address non-compliance issues, and implement corrective actions to strengthen their biosafety programs. Whether preparing for routine inspections or facing an unanticipated audit, this course will provide invaluable guidance and practical strategies to navigate regulatory audits confidently and successfully.
Objectives:
- Develop a comprehensive audit preparation plan incorporating documentation requirements outlined by regulatory agencies such as the CDC, NIH, and OSHA
- Demonstrate proficiency in identifying potential audit pitfalls and addressing non-compliance issues within a biosafety program
- Interpret audit findings and implement corrective actions to strengthen a biosafety program and improve regulatory compliance practices
Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Worker
Audience Level: Intermediate
COURSE FACULTY
Sarah Ziegler, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)Sitero
Coral Gables, FL
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, December 3 and Thursday, December 5, 2024, 11:30 AM – 1:30 PM CST
Registration is closed for this webinar. You may purchase the recording.
6V. Disposal of Research Animal Carcasses
This course will focus on research-based, unique scenarios presented with animals in research and diagnostic environments. Course topics include: composting, incineration, rendering challenges, carcass movement, unique agent requirements, complex variety of animal species (large, small, wildlife, companion, research, diagnostic), mixed hazard waste issues. The attendees will see strategies to assess risk and apply best practices and regulatory requirements to common and diverse situations. Course will be interactive, with breakout sessions and real-world examples.
Objectives:
- Develop, evaluate, and document waste and carcass handling procedures for animals administered biohazardous agents and materials
- Develop procedures and practices to prevent release of infectious materials related to animal carcass disposal
- Identify the steps in the coordination of stakeholders for animal carcass disposal requirements
Suggested Background: None
Target Audience: Animal Caretakers, All Safety Professionals, Experienced Biosafety Professionals
Audience Level: Intermediate
Course Length: 4 hours (two 2-hour live sessions)
Within 10 business days of purchasing the recording, you will be added to the course on the ABSA International Training Site. If you have already taken ABSA courses, then you will receive an enrollment notification. If you are a new user, you will receive an invitation to create your account on the ABSA International Training Site. Once the account is created, you will see the course on your course dashboard. You will have 60 days to complete the course.
COURSE FACULTY
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. 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.