Starts in:
In-person Professional Development Courses
All times listed are in MOUNTAIN STANDARD TIME
Sunday Courses
Sunday, November 3, 2024
JW Marriott Phoenix Desert Ridge
Sunday, November 3, 2024, 8:00 AM – 5:00 PM
14. Medical Emergencies in the Laboratory – Are you prepared?
Biological Sciences form the foundation of medical research and healthcare including: biochemistry, molecular, cellular, developmental biology, microbiology, plant biology/pathology and public health. Biosafety professionals regularly train staff to handle spills, exposure to chemicals, weather related events, power outages, and biosecurity, but what about medical emergencies? Your organization may have emergency response procedures, but are the individuals in the lab, field, or even visitors prepared to handle first aid in situations involving biologicals? Personnel should be able to recognize and react to medical emergencies they may encounter at your institution involving biologicals. Early recognition of potential medical emergencies can reduce long-term or deadly consequences and legal challenges. Medical emergencies may involve only one individual or it can be a large-scale emergency. Prepare your personnel to respond appropriately in order to avoid worsening the situation. Discover ways to improve communication and cooperation with internal emergency response teams and local emergency responders (911 operators, fire, EMS, law enforcement) when biologicals are involved. Consider the impact when First Responders arrive on scene and see a BSL-2 or BSL-3 sign. If an ambulance is required, is the patient ready to transport? Although you cannot predict every emergency, preparing your personnel to think through a response by preplanning for an event and the steps to recovery is necessary to simplify an emergency response. This class will offer guidance and assistance in preparing for emergencies.
Objectives:
- Establish relationships with local emergency response
- Summarize the right response in a medical emergency
- Communicate the decontamination procedures to employees and emergency responders
Suggested Background: Basic first aid
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
COURSE FACULTY
Deborah Howard, MPH, CBSP(ABSA)
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
North America Biosafety Manager
BASF
Durham, NC
Anita Harrell has 10 years of experience in the fields of Occupational Safety, Biological Safety and Laboratory Safety. She has worked at BASF for 35 years and is currently the North America Biosafety Manager. Prior to joining BASF, Anita worked at North Carolina State University in Raleigh, NC. She received a degree in Botany from NCSU in 1983. Anita currently oversees the North American Biological Safety Programs. She works with site biosafety representatives to oversee these areas. She participates and several global biosafety teams at BASF.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 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, 8:00 AM – 5:00 PM
18. ISO 35001 Implementation Course
In 2019, ISO published a new biorisk management standard that many biomedical research laboratories all over the world are adopting. This course will provide presentations, facilitated discussions and tools to introduce concepts related to biosecurity and biosafety (biorisk) management systems. Participants will learn in-depth both the theory of biorisk management (BRM) systems and how to use the new laboratory biorisk management framework ISO 35001 as a planning tool to map their existing management system to the new standard and identify and prioritize opportunities to improve their existing system using the new ISO standard. Using the ISO 35001 as a planning and mapping tool will enable institutions to effectively identify, assess, control, and monitor the laboratory biosafety and biosecurity risks associated with hazardous biological materials using the concept of continual improvement through the PDCA (Plan-Do-Check-Act) principle.
Objectives:
- Identify the key elements of a BRM system based on the review sections of the ISO 35001 BRM system standard
- Map their existing BRM systems to the ISO 35001 and identify both strengths and opportunities to improve existing system
- Prioritize elements or areas that need improvement
- Select an area for improvement and identify a simple, short term, project idea to help strengthen one element within their existing system
Suggested Background: None
Target Audience: Experienced Biosafety Professionals, All Safety Professionals
Audience Level: Advanced
COURSE FACULTY
Eric Cook, MPH
Senior Member – Technical Staff
Sandia National Laboratories
Albuquerque, NM
Eric Cook is a Senior Member of the Technical Staff in the International Biological and Chemical Threat Reduction Program at Sandia National Laboratories where his work focuses on promoting global laboratory biorisk management. He serves as one of the program’s lead trainers. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he managed the Biosafety Program and Institutional Biosafety Committee. Prior to working at Dartmouth, Eric was an Assistant Biosafety Officer at the Massachusetts Institute of Technology for six years. While at MIT, Eric completed his Master’s Degree in Public Health at Boston University with a focus on Environmental Health. Eric has a B.S.in Molecular Biology from Brigham Young University where he worked in a recombinant DNA lab for two years assisting with work in phylogenetics. He is certified by the National Registry of Certified Microbiologists as a Specialist Microbiologist in Biological Safety Microbiology and previously by ABSA International as a Certified Biological Safety Professional. Eric has particular expertise in dangerous goods and infectious substance shipping. He worked for three years at Saf-T-Pak, Inc. developing training programs and packaging for shipping infectious substances.
Rawan Khasawneh
Team Leader
Biorisk Management Training Division
Princess Haya Biotechnology Center
Jordan University of Science and Technology
Irbid, Jordan
Rawan Khasawneh is the team leader of biorisk management training division (BRMTD) at Princess Haya Biotechnology Center / Jordan University of Science and Technology. Her work focuses on developing and implementing strategic and sustainable biorisk management training on a regional basis. She is responsible for the coordination of biorisk management training events for professionals of different sectors from Jordan and the MENA region, and teaching them using interactive learning techniques. Ms. Khasawneh has implemented several projects with national and international organizations to support the building up and improvements of biorisk management system in the MENA region. In addition, she has experience in the biotechnology field in diagnostic and research labs where she used molecular techniques such as microarray, DNA sequencing, real-time PCR, and conventional PCR to study the genetics of cancer, gene expression, and detection of viral agents. She obtained her master of science in applied medical sciences from Jordan University of Science and Technology, and professional certification in biorisk management and biosecurity from the International Federation of Biosafety Associations (IFBA).
Kalpana Rengarajan, PhD, MPH, JM, RBP(ABSA)
Director of Research Safety | Senior Biosafety Officer
Emory University
Atlanta, GA
Kalpana Rengarajan is the Director of Research Safety at the Environmental Health and Safety Office (EHSO) and is the Senior Biosafety Officer for Emory University. EHSO has University-wide responsibility for all aspects of Environmental Health and Safety support, including Biosafety and EHS compliance support to Emory Healthcare. This includes biosafety support to the Emory Serious Communicable Diseases Unit (SCDU), which cared for 4 Ebola patients in 2014. The SCDU continues to be a major leader in the U.S. National Ebola Training Center. Her background includes a PhD in Immunology and she has worked as a Visiting Associate at the National Eye Institute, NIH. Prior to joining EHSO she worked as a Research Associate at the Emory Vaccine Center. Kalpana has a passion for Global Biorisk Management Public Health Preparedness and provides guidance internationally. She has a Masters of Public Health from Rollins School of Public Health (Emory University) and a Juris Masters of Law (Emory University). She is a Registered Biosafety Professional. Dr. Rengarajan serves on committees for the ABSA International (American Biological Safety Association) and the Campus Safety Health and Environmental Association (CSHEMA), to create professional development courses, and is a member of the technical writing team for ISO/TC 212/Working Group 5 (ISO Laboratory Biorisk management standard), and was a technical writer for the CEN Workshop Agreements relating to Biorisk Management Systems: CWA 15793:2011 and 16393: 2012. Dr. Rengarajan regularly teaches/facilitates and presents at ABSA and CSHEMA. She has also been teaching for the Laboratory Leadership Service (LLS) program at CDC.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 7.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 12:00 PM
19. The Big, Bright Beautiful World of BSL-2
In the world of biosafety, balancing risk management with potential uncertainties can be tricky. We have all heard the adage that in biosafety, “it depends”, and nowhere is this a more accurate statement than in a biosafety level 2 (BSL-2) laboratory. Unlike the clear-cut requirements of other containment levels, BSL-2 boasts a spectrum of flexibility that can be both empowering and confusing. Housing agents from Risk Group categories 1 through 3, BSL-2 laboratories can resemble the “wild west” of biosafety. While this adaptability allows tailored safety protocols, it also provides a breeding ground for uncertainty and potential for error. When does a BSL-1 space become a BSL-2 lab or BSL-2 become a BSL-3? Where do recommendations end and requirements begins? When can an RG-3 agent be handled in a BSL-2 laboratory, and why? From understanding airflow requirements and choosing the right biosafety cabinet (if you need it) to choosing crafting functional safety protocol and assessing the highly controversial BSL-2+, this course is intended for the biosafety novice to delve deeper into the ever fluid BSL-2 space and gain confidence navigating the waters where “it depends”.
Objectives:
- Distinguish between recommendations and requirements for BSL-2 laboratories
- Identify when RG-3 agents are handled under BSL-2 containment and when should RG-1 agents be moved to BSL-2
- Restate how to adjust the 3 risk mitigation controls to get to meet specific biosafety needs and what is “BSL-2+”
Suggested Background: None
Target Audience New Biosafety Professionals, Laboratory Workers, Clinicians, EHS, Other safety professionals who work with biological materials
Audience Level: Basic
COURSE FACULTY
Heidi Page, MS, RBP(ABSA)
SABAI Global—Shield Consulting
Chesterfield, MO
Heidi has extensive experience in, and passion for, the ‘grey zone’, intertwining regulation, safety and human behavior to find the best overall solutions to the safety and compliance challenges we face when doing research. Heidi has 15+ years of experience in the field of biosafety and has over 7 years of experience serving as the Biological Safety Officer and Assistant Director of Environmental Health and Safety at Case Western Reserve University. She earned a BS in Organismal Biology from the University of Kansas, a MS in Cell and Molecular biology from University of Missouri—Kansas City and is a Registered Biosafety Professional with ABSA International. In her role as the Director of Sabai’s Shield Consulting group, Heidi has the opportunity to work with varied clients from academic institutions, CROs, startup biotechs, large pharma, and healthcare institutions. Outside of work Heidi is often found trying her hand at something new, be it gardening, cooking, raising chickens or keeping bees. She feels passionately that there is always something new to learn.
CONTACT HOURS
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 3.5 P.A.C.E.® contact hours.
Sunday, November 3, 2024, 8:00 AM – 12:00 PM
20. Implementing Field Biosafety Levels: Standardizing Safety Across Disciplines
The challenge of standardizing biosafety in field settings, especially in studies involving zoonotic disease transmission, has historically been complicated by inconsistent guidance from various institutional biosafety committees, Institutional Animal Care and Use Committees (IACUCs), and governmental agencies. This inconsistency often stems from differing levels of field experience and expertise among these groups. This course will address this gap by introducing a set of innovative Field Biosafety Levels (FBSLs) aimed at establishing uniform safety guidelines applicable to all researchers, regardless of their scientific discipline or the nature of their field work. This course will guide attendees through the critical processes of identifying primary hazards, conducting thorough risk assessments, and applying the novel FBSL framework effectively in their projects. By following a structured hierarchy of hazard controls, the FBSL framework provides the first comprehensive, risk-based guidelines designed to enhance health preparedness, enforce rigorous hygiene practices, ensure effective decontamination procedures, and manage waste efficiently. Additionally, the course will explore a tiered system of personal protective equipment (PPE) selection, tailored to varying levels of exposure and risk. Attendees will leave with a deeper understanding of how to integrate these standards into their fieldwork, resulting in improved safety outcomes and reduced risk of pathogen transmission. This course is crucial for researchers seeking to elevate the safety protocols of their field studies, providing them with the tools and knowledge to implement best practices consistently and effectively.
Objectives:
- Identify and apply FBSLs to effectively apply standards to various types of field research
- Apply techniques to conduct thorough risk assessments tailored to field settings
- Implement enhanced health and safety protocols
Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety® (PPB), Risk Assessment, Virology/Viral Vectors
Target Audience: All Safety Professionals, Scientists conducting activities in the field
Audience Level: Basic
COURSE FACULTY
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
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.