Professional Development Courses
All times listed are in CENTRAL TIME ZONE
Sunday Courses
Sunday, October 15, 2023
CHI Health Center, Omaha, Nebraska
Sunday, October 15, 2023, 8:00 AM – 5:00 PM, Room 208
12. Introduction to the ISO35001: Biorisk Management for Laboratories and Other Related Organizations
As there is a demand for stringent and robust system for handling risks of biological materials internationally; ISO 35001 has been published as the first international standard that defines the requirements of the biorisk management system for laboratories or any other organization that works with biological agents. ISO 35001 complements existing international standards for laboratories, and is appropriate to the nature and scale of any laboratory or organization that works with, stores, transports, and/or disposes of hazardous biological materials. The commitment to follow the ISO35001 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. Institutions can use the standard as a framework for improving overall biorisk program performance, raising awareness, improving international collaboration and communication, fulfilling legal requirements and supporting lab certification.The course will start with an introduction to the ISO35001, brief introduction to the major sections including leadership, planning, support, operation, performance evaluation and improvement, followed by a discussion about how to initiate implementation to improve biorisk management system. Through facilitated discussions and activities, participants will leave the course with a plan of action to perform a gap analysis of their current management system with the new ISO standard and begin a stepwise implementation process to improve existing systems and qualify for eventual ISO35001 certification.
Objectives:
- Distinguish the ISO35001 as an international standard for laboratory biorisk management requirements
- Recognize the main sections of the ISO35001
- Explain how to initiate the use of the ISO35001 to improve the overall laboratory biorisk management system
- Plan a stepwise process to analyze and improve existing biorisk management systems to qualify for eventual ISO35001 certification
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals, International Biosafety Professionals
PDC Level: Basic
COURSE FACULTY
Eric Cook, MPH
Senior Member – Technical Staff
Sandia National Laboratories
Albuquerque, NM
Eric Cook is a Senior Member of the Technical Staff in the International Biological and Chemical Threat Reduction Program at Sandia National Laboratories where his work focuses on promoting global laboratory biorisk management. He serves as one of the program’s lead trainers. Eric served as the Biosafety Officer for Dartmouth College in Hanover, NH for five years where he managed the Biosafety Program and Institutional Biosafety Committee. Prior to working at Dartmouth, Eric was an Assistant Biosafety Officer at the Massachusetts Institute of Technology for six years. While at MIT, Eric completed his Master’s Degree in Public Health at Boston University with a focus on Environmental Health. Eric has a B.S.in Molecular Biology from Brigham Young University where he worked in a recombinant DNA lab for two years assisting with work in phylogenetics. He is certified by the National Registry of Certified Microbiologists as a Specialist Microbiologist in Biological Safety Microbiology and previously by ABSA International as a Certified Biological Safety Professional. Eric has particular expertise in dangerous goods and infectious substance shipping. He worked for three years at Saf-T-Pak, Inc. developing training programs and packaging for shipping infectious substances.
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.
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).
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 – 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)
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)
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)
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.
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 – 5:00 PM, Room 207
14. Advanced BSL-3 Facility Operations
This advanced course is a follow up to the BSL-3 Facility Operations and Management and will focus on detailed aspects of biocontainment operations of BSL-3, ABSL-3 and enhanced BSL-3 laboratories. It will cover developing risk assessments for biocontainment equipment; facility operations and maintenance SOP’s; maintenance personnel training requirements; solid and liquid waste decontamination equipment, procedures, validations and cycle developments; area decontamination methodologies, procedures and validations; filtration systems and their validation and testing process; ventilation control methodologies and ventilation equipment configuration; facility testing during normal and failure conditions of the ventilation system; test documentation and record keeping.
Objectives:
- Explain the facility verification process in detail, including recommended test methodologies
- Identify the methodologies for decontamination of areas, equipment, filters and waste
- Describe the elements of biocontainment equipment risk assessments
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Experienced Biosafety Professionals
PDC Level: Advanced
COURSE FACULTY
John Henneman, MS, RBP(ABSA)
Senior MEP Manager
Gilbane Building Company
Cleveland, OH
John Henneman has worked in scientific research and then managed the day-to-day facility operations of high containment research laboratories since 1983. He currently serves as Senior MEP Manager, Gilbane Building Company, providing his expertise in building new laboratories. In the past, John has served as Director, Biocontainment Operations, Biocontainment Facility Engineer, Biosecurity Research Institute, Kansas State University for over five and a half years, manager of The Pennsylvania State University’s (PSU) Pell Laboratory for Advanced Biological Research for almost six years, and for fifteen and a half years at Battelle Biomedical Research Center, he started up a ABSL-3, added two additions, coordinated and oversaw facility maintenance and worked with research staff members and numerous contractors to schedule and carry out maintenance activities safely and efficiently. His expertise includes the design, construction, commissioning, engineering, biorisk management and operation of biocontainment facilities, along with the unique ability to understand researcher needs and equip the facility to accommodate them. John has served as Chairman of an Environment, Safety, Health, and Surety Committee, served on PSU’s Institutional Biosafety Committee and Process Safety Management Focus Group, and is an ABSA International (American Biological Safety Association) Registered Biosafety Professional (RBP). He has also been an instructor or lecturer on research building operations for ABSA and the Eagleson Institute. He served as one of ABSA’s representatives to the NIH Design Requirements Manual revision committee, as a leader of the ABSA task team supporting ABSA’s involvement in the American National Standards Institute (ANSI) committee to revise the national standard for the verification of BSL-3 facility performance (ANSI Z9.14-2020). John also participated with the non-government review team to provide a revised version of Biosafety in Microbiological and Biomedical Laboratories (BMBL) Appendix D – Agriculture Pathogen Biosafety, for the 6th edition of the BMBL. He currently serves on the ABSA Credentialing Evaluation Board (CEB).
Miguel Grimaldo, DSc., MEng
Assistant Professor | Director
Department of Pathology | Institutional Biocontainment Resources
University of Texas Medical Branch—Galveston, Galveston, TX
Miguel Grimaldo is an Assistant Professor for the Department of Pathology and the Director of Institutional Biocontainment Resources at the University of Texas Medical Branch—Galveston (UTMB), Galveston, Texas. He is also the Director of the Biocontainment Engineering Division for the Galveston National Laboratory. His responsibilities include reviewing all design, construction, commissioning, and operation of UTMB’s containment laboratories. He also ensures regulatory compliance and conducts ongoing evaluation and recertification on all critical containment features, equipment, and operations for Biosafety Level 3 (BSL-3), Animal Biosafety Level 3 (ABSL3), and Biosafety Level 4 (BSL4) laboratory facilities at UTMB. He also is a member of the UTMB Institutional Biosafety Committee. Dr. Grimaldo obtained two Bachelor of Science degrees in the fields of Agricultural Engineering and Agricultural Economics from Texas A&M University (USA), his Master of Engineering in Engineering Management from the University of Louisville (USA), and his Doctorate in Applied Biochemistry from the Federal University of Vicosa, Minas Gerais (Brazil). Before coming to UTMB in 2005, he worked for 13 years for the U.S. Department of Agriculture (USDA) at the US Embassy in Panama. He was involved with USDA’s Foot and Mouth Disease Prevention Program and the Screwworm Eradication Program. Dr. Grimaldo has served as a Committee Member for the development of the ANSI Z9.14-2014 Standard – Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities as well as for the 2016 Edition of the National Institute of Health (NIH) – Design Requirements Manual (DRM) for Biomedical Laboratories and Animal Research Facilities. Currently, Miguel serves as Project Lead for the re-write of the chapter on Biosafety and Biosecurity of the Manual for Diagnostic Tests and Vaccines for Terrestrial Animals for the World Organization for Animal Health (WOAH) and Member of the Senior Expert Team for Bio-risks Management in the ZODIAC National Laboratories (ZNLs) for the International Atomic Energy Agency. He routinely serves as Biorisk and Biocontainment Advisor for containment laboratories nationally and internationally on design, construction, and operations.
J. Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA)
Biosafety Engineer
Director of Biocontainment Operations
Cornell College of Veterinary Medicine
Ithaca, NY
Paul Jennette holds Bachelor’s and Master’s Degrees in Environmental Engineering from Cornell and the University of Massachusetts, respectively, and is both a Registered Professional Engineer and a Certified Biological Safety Professional. Since 1999, he has held the position of Biosafety Engineer at the Cornell College of Veterinary Medicine and has also been the Director of Biocontainment Operations there since 2013. Paul’s responsibilities include: design, verification, operation, decontamination, and program management related to Cornell’s BSL-3, ACL-3, and ABSL-3 facilities, which include both research & diagnostic laboratories as well as a BSL-3 large animal necropsy; training all Cornell BSL-3 scientific and support staff and providing direct, in-containment support for BSL-3 diagnostic operations; directing the operations of Cornell’s medical and pathological waste treatment facility, which includes a 5,000-lb/batch carcass digester; serving on Cornell’s Institutional Biosafety Committee and directing the Cornell Vet College Rabies Risk Management Program. Paul serves on biosecurity teams for Select Agent Labs at the Cornell Vet College and provides technical support for the College’s effluent decontamination systems. He served as the American Biological Safety Association’s representative on the ANSI committee to develop a national standard for the verification of BSL-3 facility performance, is a reviewer and lead author of a technical column for the Applied Biosafety journal, and is a member of ABSA’s Professional Development Team. He is a former co-chair of ABSA’s Principles & Practices of Biosafety class as well as a regular instructor for BSL-3 courses offered by the Eagleson Institute and ABSA. In addition to his position at Cornell, Paul provides biocontainment operations consulting services to a variety of academic, governmental, and pharmaceutical clients.
Daniel Cook, LEED AP
Director of Critical Projects
Cornerstone Commissioning, Inc.
Boxford, MA
Dan Cook is the Director of Critical Projects with Cornerstone Commissioning, a firm dedicated to transforming the delivery of high performance facilities through its hands-on commissioning process. Dan oversees all documentation and process for the firm, along with all aspects of commissioning biocontainment laboratories and mission critical facilities. Dan is an instructor at the Eagleson Institute – Verifying BSL-3 Performance and has spoken at national conferences for BCxA – Building Commissioning Association, ABSA – American Biological Safety Association, CDC – Center for Disease Control and Prevention Biosafety Symposium, and ASHRAE – American Society of Heating, Refrigeration and Air conditioning Engineers on the topic of biocontainment commissioning. Dan is a LEED-accredited professional with twenty three years of experience in the building controls and commissioning industry. He served six years in the US Navy working on shipboard weapon direction systems.
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 – 5:00 PM, Room 210
15. Advanced Risk Assessment
In this advanced and interactive course, participants will evaluate a variety of challenging scenarios based on actual research protocol submissions and real-world events from multiple risk perspectives. Participants will work in teams to conduct risk assessments on a diverse selection of scenarios that will include multiple systems used in research as a research project progresses from discovery to cell culture, to small animal models using recombinant materials, and human clinical trials. Risk assessments will focus on the likelihood of exposure and the severity of consequences from exposure to the multitude of hazards encountered in increasingly complex research as well as the surprises that may come across the biosafety officer’s desk. Participants will be challenged to consider additional risks aside from infection and how best to mitigate them. Participants should have a thorough understanding of pathogenic microorganisms, rDNA principles, other infectious substances and the link between biosafety, risk assessment, and risk mitigation for this advanced course. There is an emphasis on the interactive nature of the risk assessment process and differing views of risk tolerance will be considered; participants should be prepared to participate in discussions and bring interesting or difficult examples of interest to them to discuss with the class.
Objectives:
- Prioritize risks based on the likelihood and consequences of an occurrence
- Identify risks requiring mitigation and mitigation strategies to minimize the unacceptable risks
- Identify institutional and external partners to help implement mitigation strategies
- Evaluate mitigation strategies for effectiveness, adjust strategies as warranted
Suggested Background: Fundamentals of Biosafety, Microbiology, and Molecular Biology; Basic Risk Assessment, Principles & Practices of Biosafety
Target Audience: Experienced Biosafety Professionals, Laboratory Workers
PDC Level: Advanced
COURSE FACULTY
In fond memory of our friend and colleague
March 2, 1978 – June 23, 2023
Angela Birnbaum, MPH, RBP(ABSA), CBSP(ABSA), SM(NRCM)
While lost far too young, Angie leaves behind an indelible mark on the world through both her career and personal life. She graduated from Springfield High School in 1996, followed by receiving her Bachelor’s Degree in Biology from the University of Illinois at Urbana-Champaign in 2001. Angie married Josh Alvies in their hometown in December 2002.
In 2004, Angie and Josh left their home to start Angie’s career in Biological Safety at New York Medical College in Valhalla, New York. Angie went on to earn her Master’s of Public Health Degree in 2011. Angie later moved to Massachusetts to continue her career at the Massachusetts Institute of Technology in Cambridge.
Later, Angie moved to Kansas to serve as a Biosafety Officer at MRI Global, where she and Josh also welcomed their daughter Caillen in 2011, followed by another time in Massachusetts at Harvard University as the Director of Biological Safety and finally to Mandeville, Louisiana to serve as Executive Director of Biosafety, Biocontainment Operations, and Quality Assurance for Tulane University and Director of Biocontainment for the Tulane National Primate Research Center. At Tulane, she oversaw a university-wide biosafety program involving research using recombinant DNA and synthetic nucleic acids, clinical trials, and research with high-risk pathogens. She was the Responsible Official for the Tulane National Primate Research Center Select Agent Program.
Angie was a Registered Biosafety Professional, Certified Hazardous Material Manager, Certified Biological Safety Professional, and a Specialist Microbiologist in the National Registry of Certified Microbiologists. Since 2007, Angie has been a member of ABSA International, and has participated in several working groups, provided numerous conference platform presentations for ABSA International and several regional affiliates. She has served on the ABSA Awards Committee since 2009, served as the Co-Chair of the Biological Select Agent Community Advocate Committee from 2017-2020, served as Co-Chair of the 2nd Biosecurity Symposium Executive Steering Committee, served as a Co-Chair of the Regional Biocontainment Laboratory Biological Safety Sub-Committee. She was a member of the Massachusetts Society of Medical Research and has provided numerous conference sessions. She had over 20 years of experience working in academic institutions and contract research organizations. Angie had a proven record of biosafety and biosecurity program implementation, complex risk assessments for emerging technologies, high containment building design, and biosafety team building. She most recently served as the Co-Investigator of the Coordinating Center for Non-Human Primate Research in COVID-19 vaccine and therapeutics, coordinating practices and procedures amongst the 7 regional primate research centers.
Beyond her career at these world-renowned institutions, Angie volunteered her time and knowledge to the Departments of State and Defense for training colleagues from the Middle East and North Africa, traveling to nations like Jordan, Tanzania, Malaysia, and Morocco to spread best practices for biological safety worldwide. She previously served on the board of the Massachusetts Society for Medical Research, served as both Vice President and President of the Southern Biosafety Association, and remained on the board, and held many positions for ABSA International, most recently as a Councilor.
For all that in her professional life, Angie considered her daughter Caillen to be her greatest achievement, and to everyone who knows her family, they will notice the striking similarities between the two in appearance, ambition, and their persistent desire to support anyone in need.
In lieu of flowers, memorial contributions in memory of Angie may be made to the American Diabetes Association at Diabetes.org/, Northshore Humane Society in Covington, LA (from where she adopted her beloved cats) at NorthshoreHumane.org/give, or to Caillen’s educational fund at www.ugift529.com with code J8J-58D.
Caillen would also love to receive memories of her mom from childhood, school, work, or any other friendship from all of the people who loved her dearly; please feel free to bring your memories for Caillen to the course in an envelope and the instructors and ABSA’s Director of Education will be sure they get to her, or you are welcome to use the online guestbook available at www.GraceNorthshore.com.
Rachel 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.
Katie George, PhD, MPA, RBP(ABSA)
Associate Partner and Human Gene Therapy Biosafety Officer
Clinical Biosafety Services
Chesterfield, MO
Katie George lives in Missoula, Montana and is currently an Associate Partner and Human Gene Therapy Biosafety Officer for Clinical Biosafety Services (Chesterfield, MO) working with clinics, universities, and hospitals in the United States and Canada prepare for IBC review of Human Gene Therapy (HGT) clinical trials.
Katie holds a BS in Biology from the University of Iowa, a PhD in Biochemistry from Northwestern University, and an MPA from Purdue University. After obtaining her PhD, she was a post-doctoral fellow at the National Institutes of Health researching mycobacterial pathogenesis. After her post-doctoral position, she served as faculty at the University of Montana teaching and leading a research team studying organophosphate pesticide toxicology. Later, she taught medical students at the Medical University of the Americas (Nevis, West Indies). During her career, Katie has worked as a toxicology consultant for the State of Montana Public Defenders and the State of Montana Department of Public Health and Human Services.
Katie has been an ABSA member since 2020 and a Registered Biosafety Professional since 2021. She currently serves on the Distance Learning Committee for ABSA International.
David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM)
Safety and Occupational Health Manager
Office of Management, Center for Veterinary Medicine
U.S. Food and Drug Administration
Dr. David Harbourt is a Safety and Occupational Health Manager for the Center of Veterinary Medicine at the U.S. Food and Drug Administration (FDA). Prior to his current position, he served as the Program Director of the National Biosafety and Biocontainment Training Program (NBBTP) at the National Institutes of Health. Before that, he served in a variety of roles at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) including Biosafety Officer, Chief of the Biosafety Division and Deputy Director of the USMARIID Transition Office (2012-2021). Prior to working at USAMRIID, he was a fellow in the NBBTP. Preceding the fellowship, he graduated with his B.S. in Biochemistry from Virginia Tech (’05) and his Ph.D. in Toxicology from UNC-Chapel Hill (’09).
Dr. Harbourt has been an active member of ABSA International since 2010; has previously served as the Chair of the Preconference Course Committee and Chair of the Training Tools and Resources Committee; and currently serves as a member of the Exam Development Board for the CBSP Exam. He has also been a member of the Standards Committee, Professional Development Team, and BSAT Community Advocate Committee for ABSA. He has recently been named Co-Chair of the ABSA Ambassadors Committee. Locally within the Chesapeake Area Biosafety Association, Dave has been a Councilor, Chair of the Scientific Program Committee for its annual symposium, and Chair of the Pre-Symposium Committee. Previously, Dr. Harbourt served as Chair of the DoD Biosafety and Scientific Review Panel.
Dr. Harbourt has published several articles on topics relevant to biosafety including bacteriology, virology, agent inactivation, effluent decontamination systems, and risk assessment. He has also taught courses both at ABSA and at local universities on biosafety, risk assessment, emergency management, and effluent decontamination systems. Dave is a Registered Biosafety Professional and Certified Biological Safety Professional through ABSA International and a Specialist Microbiologist (NRCM) through the American Society of Microbiology.
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 209
16. Capturing and Displaying the Value of Your Biosafety Program
A recurrent challenge confronting biosafety professionals is the ability to garner necessary program resources to achieve desired goals and objectives. The basis for this difficulty is that, on a good day in the world of biosafety, “nothing bad happens”. The underlying challenge is that upper management may not fully appreciate or understand all of the effort and resources that went into making “nothing bad happen”. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course focuses on some key management approaches and techniques that can be used within biosafety programs to help improve stakeholder understanding, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques presented will be displayed for review and discussion. Ample time will be provided throughout the course for participant interaction and inquiries.
Objectives:
- Identify various biosafety programmatic measures and metrics that should be captured and communicated
- Describe how biosafety programs can assist with other basic safety program needs to help avoid the notion of program duplication of efforts and to improve safety and client satisfaction levels
- Paraphrase techniques used for displaying biosafety data in ways that others can readily understand and appreciate
Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals
PDC Level: Basic
COURSE FACULTY
Robert Emery, DrPH, chp, cih, csp, chmm, cpp, ARM, RBP(ABSA), CBSP(ABSA)
Vice President of Safety, Health, Environment & Risk Management
University of Texas Health Science Center—Houston
Houston, TX
Robert Emery is Vice President for Safety, Health, Environment & Risk Management for The University of Texas Health Science Center at Houston (UTHealth Houston) and Professor of Occupational Health at the University of Texas School of Public Health. Bob is a board licensed Medical Health Physicist, a Certified Health Physicist (CHP), Certified Industrial Hygienist (CIH), and a Certified Safety Professional (CSP). He holds both ABSA International credentials; the Registered Biosafety Professional (RBP) and Certified Biological Safety Professional (CBSP).
Scott Patlovich, DrPH, CIH, CSP, CHMM, CPH, CBSP(ABSA)
Assistant Vice President of Environmental Health & Safety
University of Texas-Houston, Houston, TX
Scott Patlovich is the Assistant Vice President of Environmental, Health & Safety at The University of Texas Health Science Center at Houston (UTHealth Houston) and an Instructor at The University of Texas School of Public Health (UT SPH).
Kristin King, DrPH, CPH, CHSP, CIC, CBSP(ABSA)
Biological Safety Manager
University of Texas Health Science Center—Houston
Houston, TX
Kristin King is the Biological Safety Program manager within Environmental Health & Safety at The University of Texas Health Science Center at Houston (UTHealth Houston).
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 – 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)
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)
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 209
18. Writing Effective Standard Operating Procedures
This course will offer participants an understanding of key principles for writing effective standard operating procedures (SOPs). An introduction to the importance of SOPs in achieving desirable and consistent outcomes and issues that must be considered in the SOP writing process will be presented. Examples will include some of the most common human behavior considerations such as compliance, behavioral evolution, complaisance, and strategies to address behavioral concerns that may arise. Participants will engage in guided discussions about the benefits of an effective SOP writing process and the most common mistakes made by the authors of SOPs. The course will take participants through the process of writing feasible standard operating procedures (SOPs) including SOP evaluation and validation. Through group interactions, participants will develop examples of SOPs to illustrate effective writing concepts, present their SOPs to the class, and evaluate each other’s SOPs for feasibility. Instructors will guide participants through the process by providing critical feedback on the SOP writing process as they progress. The goal of this course is to increase students’ awareness of issues that arise when writing standard operating procedures and how these issues affect SOP compliance. Furthermore, the course will provide examples of well-written SOPs that contribute to overall SOP compliance at an institution. The course is intended for those who want to be able to lead or aid in the creation of feasible and effective SOPs in order to enhance both biosafety and biosecurity at their institution.
Objectives:
- Summarize the range of issues that must be considered when writing effective standard operating procedures (SOPs), including human behavior
- Develop strategies for writing effective SOPs
- Illustrate how good standard operating procedures (SOPs) work to enhance both biosafety and biosecurity
- Recognize the value of “feasible” and therefore effective standard operating procedure (SOP) in promoting biosafety and biosecurity best practices
Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
PDC Level: Basic
COURSE FACULTY
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, 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.
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)
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)
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 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.