64th Annual Biosafety and Biosecurity Hybrid Conference

Professional Development Courses

Professional Development Courses
Scientific Program | Posters

1V – IBC Basics

October 1, 2021
IBC Basics will focus on the function and administration of Institutional Biosafety Committees (IBCs). Delivered by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP), IBC Basics will promote the professional development of those associated with IBCs, by providing an opportunity to: learn about the role of NIH OSP; the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, and understand the range of biosafety oversight responsibilities that IBCs have under the NIH Guidelines. This course provides an introductory level overview and may be helpful for those new to the field or for those who are also interested in the Promoting Biosafety and Biosecurity through Effective Governance workshop.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Summarize the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules
  • Identify the requirements for IBCs under the NIH Guidelines
  • Restate the partnership between NIH OSP and IBCs in the oversight of research subject to the NIH Guidelines

COURSE FACULTY
Kathryn Harris, PhD, RBP(ABSA), National Institutes of Health, Bethesda, MD
Kevin Ramkissoon, PhD, National Institutes of Health, Bethesda, MD

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
New Biosafety Professionals, IBC administrators, members, and staff

AUDIENCE LEVEL
Basic

COURSE LENGTH
4 hours (one 4-hour live session with a 1-hour break)

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

2V – Personnel Security in Laboratory Biosecurity Programs

September 14 and 16, 2021
Personnel security is comprised of security measures focused on people and behaviors rather than typical physical barriers approaches. Personnel security can be thought as the “administrative controls” in any advanced security program. This course will teach administration, management, and researchers the basic principles of threat assessment and introduce students to the role of comprehensive personnel security in a laboratory biosecurity program. The course is intended to give students a basic toolkit that will allow them to implement successful comprehensive insider threat mitigation strategies using personnel security approaches at their home institutes and to convey concepts in personnel security to their colleagues. Participants will be presented with relevant case studies to learn about relevant threats in the biomedical and health sectors. Participants will learn about all aspects of personnel security including suitability, reliability, peer and self-reporting strategies, threat assessment, OPSEC, INFOSEC, and an introduction to elicitation, manipulation, and surveillance awareness. These concepts will be put into practice in interactive, live role-playing scenarios that include interview tactics, deception detection elicitation and surveillance detection. Regulatory issues relevant to implementation of personnel security management programs, in particular the Select Agent Regulations pertaining to Tier 1 agents, will also be discussed.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Identify the types of threats posed to biomedical research, public health and clinical diagnostic facilities and institutions and describe some of the tools that can be used to assess these threats
  • Identify the main components of laboratory security programs
  • Describe how each mitigates the threats above and the unique role that personnel security programs play in insider threat mitigation
  • Restate the purpose, requirements and major components of personnel security programs

COURSE FACULTY
Benjamin Perman, PhD, RBP(ABSA), U.S. Coast Guard, Washington, DC
Lindsay Odell, PhD, U.S. Army Reserve, Fort Detrick, MD

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers

AUDIENCE LEVEL
Basic

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

3V – Animal Research for Biosafety Professionals—An Introduction

September 8 and 10, 2021
Animal Research has contributed to major scientific advances in biomedical, veterinary, and environmental sciences and in public health. However, these efforts often pose significant risks to the health and safety of research and facility staff due to the wide range of species, complex experimental procedures and equipment, and facility hazards that are involved. Balancing optimal worker safety and animal welfare with research objectives yields the best results, but requires a solid understanding of how animal programs are managed and an ability to identify and mitigate inherent risks. This course provides a thorough introduction to routine hazards commonly encountered in animal programs that utilize rodents, small animals, nonhuman primates, aquatics, and agricultural species, with a primary focus on identifying and managing biological, chemical, radiological, and physical hazards. The instructors are experienced laboratory animal veterinarians who are actively involved in the management, oversight, and evaluation of animal care and use programs. Topics include: assessment and management of animal program hazards; universal regulations, guidelines, and quality standards that apply to animal research; duties and responsibilities of key program personnel; local oversight systems; best practices that enhance the quality of animal care; and strategies for biosafety professionals to develop and maintain effective partnerships with program staff and institutional animal care and use committee members. Opportunities will be provided to apply new knowledge and skills through group interactive activities and problem-solving sessions.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Review basic hazard identification and risk assessment techniques relevant to research involving live animals
  • Summarize the governing regulations and guidelines that pertain to the care and use of research animals, recognizing the difference between “regulatory requirements” and “best practices” that relate to performance-based standards
  • Identify successful strategies for working effectively with animal program personnel on common research safety issues

COURSE FACULTY
Susan Harper, MS, DVM, DACLAM, DACVPM, RBP(ABSA), USDA Agricultural Research Center, Beltsville, MD
Lesley Colby, MS, DVM, DACLAM, Univeristy of Washington, Seattle, WA

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers

AUDIENCE LEVEL
Basic

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

4V – Plant Biosafety for Laboratorians, Greenhouse Safety and Support Personnel at Universities, Startup and Agricultural Companies

September 29 and 30, 2021
Plant research is the backbone of both genetically modified, disease resistance, and breeding of both academic and biotechnology research. This course will provide participants with an overview of APHIS, BRS, and VS permitting. It will also cover the NIH Guidelines as it relates to environmental release and financial loss. The course will offer a variety of advanced scenarios and interactive exercises that demonstrate the range of biological, genetically modified, and other risks and hazards routinely encountered in the greenhouse, fields and labs supporting plant research. Participants will be guided through strategies for identifying potential hazards, assessing the magnitude and extent of induced risks and cost, and developing effective control measures to protect the safety of workers, plants, and the environment. The course employs “real world” examples to improve understanding of greenhouse and field operations.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Review basic import permits, hazard identification, and risk assessment techniques as they apply to research involving genetically modified (GM) plants
  • Paraphrase how to incorporate effective hazard and exposure control strategies into GM and arthropod lab, greenhouse design, and research facility management procedures
  • Identify ways that safety professionals can work with plant program personnel to address common research safety issues and environmental issues

COURSE FACULTY
Deborah Howard, MPH, CBSP(ABSA), BASF, Efland, NC
Kirt Poulsen, Utah State University, Logan, UT

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Biosafety Professionals, All Safety Professionals

AUDIENCE LEVEL
Basic

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

5V – Infectious Substance Shipping Certification

September 20, 21, 22, 23, 24, 2021
This course is appropriate for both those who have some experience with infectious substance handling or shipping but may not have been certified within the past 3 years and those with little to no previous training. The course will be administered in five, 1.5-hour virtual sessions, Monday – Friday. There will be group discussions and interactive exercises focused on the essential areas of infectious substance shipping. New IATA requirements for competency assessment will be administered in daily, short interactive homework assignments, and a new online exam. Participants will mark, label, package, and complete documentation for infectious substance shipments (Category A, Category B, and Exempt Patient Specimens), and review applicable regulations with a focus on IATA. Additional US DOT differences will also be addressed. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. Participants have both an online exam (score at least 80%) and practical exercises to demonstrate competency. Successful completion of the course will qualify participants for IATA/DOT certification.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Review of applicable regulations with a focus on IATA, the nine classes of dangerous goods, and general definitions
  • Apply the key components of Packing Instruction 620, 650 and 954 for Category A, B and dry ice and specific use of overpacks
  • Classify biological materials for shipping purposes as either Category A, Category B, Exempt, or not regulated based on the principles of risk assessment and regulatory definitions
  • Demonstrate how to package, mark, label, and document shipments for infect

COURSE FACULTY
Eric Cook, MPH, CBSP(ABSA), Sandia National Laboratories, Albuquerque, NM

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers, Shipping Infectious Substances Personnel

AUDIENCE LEVEL
Basic

COURSE LENGTH
8 hours (classwork and five 1.5-hour live sessions)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

6V – BSL-2 Enhanced Work Practices: How to Develop a Training Program that Works for Your Institution

October 7, 2021
This course will focus on how enhanced work practices can be incorporated into the biorisk assessment and management process for the safe use of biohazardous materials in research and clinical environments. The use of advanced work practices will be demonstrated as part of the plan-do-check-act pathway for developing a risk control strategy and in the selection of risk control measures as identified in the World Health Organization’s Laboratory Biosafety Manual 4th Edition. This is also pertinent in the CDC/NIH BMBL 6th edition, which recognizes in some cases “a more cautious approach to containment utilizing elevated biorisk management practices is warranted (e.g., BSL-2 with enhanced practices, procedures, and facilities.)”. This course will demystify the risk assessment pathway to determine when more biocontainment may be required. The 7 five-minute video modules developed by the presenters serve as the core for this course as a comprehensive array of best practices that adds to the biosafety professional’s arsenal of training for personnel in clinical and research laboratories. When a biorisk assessment determines that more containment is warranted, the tools and discussion this course will offer can assist with the development of these additional biocontainment measures. Participants will learn how to utilize these short enhanced biorisk management training tools to develop site-specific training programs to reinforce advanced practices for their own institutions. The presenters recognize that “enhanced biorisk management practices” has many definitions. The goal of this class is not to teach one set of defined enhanced biorisk management work practices. It is to guide the participants on a pathway that identifies those work practices that best fit their site-specific biorisk management protocols, while maximizing protection of those performing medium to higher risk research and laboratory activities and helping to ensure confinement of biohazards where they are handled.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Use a risk assessment to determine when BSL-2 enhanced work practices should be implemented
  • Create a BSL-2 enhanced training program at their own institution
  • Utilize the tools provided to conduct hands-on BSL-2 work practices assessment observations

COURSE FACULTY
Danielle Scavone, MS, RBP(ABSA), Yale University, New Haven, CT
Maren Schniederberend, PhD, Yale University, New Haven, CT

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, New Biosafety Professionals, Laboratory Workers

AUDIENCE LEVEL
Basic

COURSE LENGTH
4 hours (one 4-hour live session with a 30-minute break)

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

7V – Capturing and Articulating the Value of Your Biosafety Program

November 1 and 8, 2021
A recurrent challenge for biosafety professionals is the ability to garner necessary program resources to achieve desired goals. The basis for this difficulty is that on a good day in the world of biosafety, “nothing happens”. The challenge is that upper management may not fully appreciate or understand all of the effort and resources that went into making “nothing happen”. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course focuses on some key management approaches and techniques that can be used within biosafety programs to help improve stakeholder understanding, which in turn can result in the provision of necessary programmatic resources. Numerous real world examples of successful applications of the techniques presented will be displayed for review and discussion. Ample time will be provided throughout the course for participant inquiries.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

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

COURSE FACULTY
Robert Emery, DrPH, CBSP(ABSA), University of Texas Health Science Center—Houston, Houston, TX
Scott Patlovich, DrPH, CBSP(ABSA), University of Texas Health Science Center—Houston, Houston, TX
Kristin King, DrPH, CBSP(ABSA), University of Texas Health Science Center—Houston, Houston, TX

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
New Biosafety Professionals, All Safety Professionals, Laboratory Workers

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

8V – Keeping it Going: Maintaining and Improving a Select Agent Program over the Long Term

October 4 and 6, 2021
Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can prove even more advantageous, elevating a good program to a great program. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of “crises” sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing Select Agent program, including strategies for anticipating and responding to new requirements. The focus will be on U.S. Select Agent requirements, although a section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their institution’s program with additional input solicited from participants during open discussions. Topics will include the history of the Select Agent program; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of presentations followed by group discussions aimed at facilitating application of strategies presented to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Review strategies in preparing for and responding to regulatory inspections and the need to implement necessary changes
  • Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns
  • Summarize inactivation requirements and identify successful strategies for compliance

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

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals—safety professional who deal with Select Agent programs

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

9V – Respiratory Protection for Biosafety Professionals

November 16, 2021
This course will provide an overview of respiratory protection personal protection equipment (PPE), including selection considerations for biological and chemical hazards. A deeper dive into key hazards relevant to biosafety professionals and their respiratory protection considerations will follow. While mostly based on U.S. OSHA Respiratory Protection Program requirements, much of the information presented will be applicable internationally.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

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

COURSE FACULTY
Kathryn Thompson, CIH, MT(ASCP), 3M, St. Paul, MN

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Biosafety Professionals, All Safety Professionals

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
4 hours (one 4-hour live session with a 30-minute break)

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

2 – Exporting Research Materials

November 3 and 5, 2021
This course targets individuals with exporting responsibilities, including deemed exports, at universities and biotech companies. Participants will learn about the fundamental research exclusion and the impact deemed exports have on your organization. Do you have foreign nationals in the workplace? Ship biological materials (or genetic elements) out of the U.S.? Export Select Agents? Ship items that cost more than $2,500 out of the U.S.? Is your software controlled? Do you have controlled “development” technical research? Participants will learn to understand the six terms of use as they relate to exports of intangible “technology”. There is more to shipping than classification, labeling, and marking. When shipping anywhere outside the U.S., including Puerto Rico, there also are licensing, under-invoicing, and ITN numbers from the U.S. Census Bureau to consider. During this workshop, participants will summarize the SNAP-R Program and how the International Traffic and Arms (ITAR) Regulations fit into exporting. Troublesome clauses in contracts will be covered. This course will discuss which pathogens and lab equipment require a license when exporting, how to obtain a license, Census Bureau requirements, recordkeeping, and much more.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Describe the exporting agencies and what items and technology they regulate
  • Recommend strategies for implementing an export management plan
  • Recognize situations where export controls apply

COURSE FACULTY
Daniel Vick, MBA, Duke University, Chapel Hill, NC
Deborah Howard, MPH, CBSP(ABSA), BASF, Efland, NC

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Biosafety Professionals, All Safety Professionals

AUDIENCE LEVEL
Basic

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

3 – Introduction to Biosafety in the Clinical Setting

October 18, 2021
The clinical setting poses a different environment than research laboratories. This course provides the foundation for applying biosafety concepts in the clinical setting. Topics covered include common issues and lessons learned pertaining to clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs and waste disposal facilities; PPE, disinfection, risk assessments and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials. The course will conclude with a focus on clinical trials including the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines and gene therapy. Discussions, surveys, and team exercises will allow participants to be highly engaged in the course content.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Apply biosafety principles in the clinical setting
  • Perform risk assessments and identify gaps in occupational safety in the clinical setting
  • Discuss the regulatory oversight structure for clinical trials and the developmental process for investigational products

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

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers, New Biosafety Professionals, Research Administration, Clinical Professionals

AUDIENCE LEVEL
Basic

COURSE LENGTH
4 hours with a 30-minute break

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

6 – Facility Commissioning for BSL-3 Containment Laboratory

October 14, 2021
By understanding the commissioning process, it can assist the biosafety professional by confidently bringing their laboratory into full operation to perform the scientific program. Laboratory commissioning is identified in containment guidance documents as quality assurance process for the effective functioning of biocontainment laboratories. The biosafety professional and other decision makers will benefit by having a fundamental understanding of the commissioning process and will allow them to articulate the engineering control data they require and to effectively participate in the process. This course will briefly review the phases of the commissioning process and allow the biosafety professional to understand how commissioning assists in providing and documenting a properly operating facility. This course will review the secondary containment features of a BSL-3 laboratory and will note specific issues typically observed during new construction as well as in renovations. The focus will then shift to specific issues typically found during commissioning; reversal of directional air flow and sealing of surfaces and penetrations. A discussion about methods to identify the issues and present some specific means to mitigate these issues. The biosafety professional can then observe (or participate) in commissioning and fully understand the methodology and results as well as understand how their facility operates correctly, its limitations, and the risk when it does not. This knowledge allows the professional to check or back check the containment spaces’ performance and allows them to use this knowledge to perform daily inspections to identify components for maintenance or replacement and control risk to the lowest level. The biosafety professional can identify required features in a new laboratory or they can review an existing lab with a better understanding of typical issues to assure safe reliable operations.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Summarize the overall commissioning process for containment labs
  • Identify the typical issues observed during commissioning of the laboratory secondary containment barriers and the options for practical solutions to those issues
  • Paraphrase how commissioning can provide a knowledge base and documentation to better perform daily inspections to reduce risk for safe and reliable laboratory operations

COURSE FACULTY
Joby Evans, PE, CAC, CBCP, Georgia Engineering LLC, Atlanta, GA

SUGGESTED BACKGROUND
Fundamentals of Biosafety

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers, Operations and Maintenance Personnel

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
4 hours with a 30-minute break

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

8 – A Practical Guide to Effluent Decontamination System (EDS) Selection, Maintenance and Operations

October 21, 2021
Involvement and knowledge is important for the biosafety professional in the selection, maintenance, and operation of their institution’s effluent decontamination system. There are numerous types and sizes of effluent decontamination systems ranging from small under the counter sink units to large thermal systems capable of treating more than 100,000 gallons per day. The first major topic covered is whether a facility requires an EDS for its operations. This need can be based on either regulatory or institutional requirements. Discussion will be held on how an institution’s research profile can tailor the EDS selection process to find the best system fit; the types of systems—chemical and thermal in either batch-based or continuous flow design and its pros/cons of each. Once an EDS is selected, participants will be instructed on the aspects of system design and installation that can affect safety and operations within a laboratory facility. Another key topic this course will discuss is the maintenance of the EDS. Maintenance requirements can vary widely between the type of EDS and whether its handled by in-house staff or external contractors. Benefits and downsides to each approach will be described along with potential effects on laboratory operations in the event of a disruption in operations. Finally, there will be a discussion of a series of case studies related to EDS operational issues in the real world setting. While there are certain aspects that will involve engineering discussions, this course is intended to be an overview for biosafety professionals to understand the right questions to ask during the selection, design, installation, maintenance, and operations of an effluent decontamination system.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Describe the types of effluent decontamination systems and what biosafety professionals need to know during installation
  • Summerize key terms for maintaining an effluent decontamination system during active laboratory operations
  • Identify lessons learned from case studies and apply them to their own facility, if applicable

COURSE FACULTY
David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Council Rock Consulting, Rockville, MD

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Biosafety Professionals, All Safety Professionals

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
4 hours with a 30-minute break

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

9 – Intermediate Threat Assessment for Laboratory Biosecurity Programs

October 19 and 20, 2021
This course is a continuation of the basic threat assessment course that presents how to structure a sustainable institutional threat assessment program in a biomedical laboratory setting. The purpose of this course is to provide laboratory staff, security managers, and responsible officials with intermediate threat assessment skills in order to identify and classify threats and effectively implement personnel security procedures that directly mitigate those threats at their institutions. The course material supports implementation of suitability and reliability programs that comply with the U.S. Select Agent Regulations for Tier 1 agents. The course is not limited to Tier 1 biosecurity solutions because it provides cost effective and minimally intrusive approaches to personnel security that is broadly applicable to all biomedical laboratories. This course targets laboratory staff responsible for developing and/or implementing effective biosecurity measures. Theoretical concepts will be put into practice in a complex interactive, 3-hour tabletop exercise involving a realistic laboratory security problem that draws on the material presented in the lecture and case studies.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Describe the application of intermediate threat assessment techniques in a laboratory biosecurity program and how threat assessment can be implemented in a successful insider threat mitigation program
  • Characterize specific personal security vulnerabilities or indicators and link these vulnerabilities to threats
  • Paraphrase the purpose and requirements of suitability, reliability, and other personnel security programs and how to successfully integrate threat assessment into these programs

COURSE FACULTY
Ben Perman, PhD, RBP(ABSA), U.S. Coast Guard, Washington, DC
Lindsay Odell, PhD, U.S. Army Reserve, Fort Detrick, MD

SUGGESTED BACKGROUND
Basic Threat Assessment for Laboratory Biosecurity Programs

TARGET AUDIENCE
All Biosafety Professionals, Laboratory Managers and Workers, Responsible Officials, Principal Investigators, Research Scientists, Non-scientific Staff (including Human Resource Administration, Facility Security Officers)

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.

11 – Evolving Role of IBCs in the Oversight of Human Gene Transfer

October 22, 2021
Over the last decade, there has been exponential growth in the pre-clinical and clinical pipelines involving gene therapies, RNA therapies, and genetically-modified cell therapies. While there has been a significant expansion in the number of clinical trials utilizing these therapeutic approaches for the treatment of cancers, rare diseases, and infectious diseases (among others), this has also come with increased pressure and responsibility on Institutional Biosafety Committees (IBCs) to expertly navigate the rapid advances in human gene transfer (HGT) technology and safely review such trials as required under the NIH Guidelines governing such research. This course will provide an overview of the current status of human gene transfer research and FDA-approved clinical applications, review commonly-used gene delivery platforms, review biosafety risks and considerations unique to the application of gene transfer in the clinical setting, and outline the evolving regulatory environment for both clinical research and clinical applications that make use of gene transfer technologies. This course will include an overview of the NIH Guidelines and IBC oversight of human gene transfer clinical trials, and how local IBCs are evolving in response to an ever-changing clinical research landscape. This will also include a review of the regulatory requirements surrounding the use of gene therapy drugs approved by the FDA in clinical trials and in clinical practice. Case studies and group discussion will be used to amplify the take home messages.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Restate the unique biosafety risks and challenges associated with human gene transfer
  • Identify the categories and risk groups of biological agents and vector systems commonly used in human gene transfer
  • Identify the key regulatory roles of IBCs in the oversight of human gene transfer research

COURSE FACULTY
Garry Coulson, PhD, RBP(ABSA), Clinical Biosafety Services, Wildwood, MO

SUGGESTED BACKGROUND
Micro/Molecular Biology 101, Institutional Biosafety Committee Basics

TARGET AUDIENCE
Experienced Biosafety Professionals, Clinical Professionals, IBC Administrators

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
4 hours with a 30-minute break

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

12 – Identifying and Overseeing Potential DURC: A Practical Guide for the Biosafety Professional

October 29, 2021
Intended to provide biosafety professionals with a strong foundation and practical knowledge for identifying potential dual use research of concern (DURC) as well as gain a greater understanding of the United States Government (USG) DURC policies, this course will directly benefit biosafety professionals in carrying out their responsibilities and help protect their institution’s research enterprise. The course structure comprises of modules broken into topic areas, followed by relevant exercises and group discussion designed to apply the information discussed. This course will introduce the current USG policies and requirements surrounding potential DURC. In addition, this course will provide strategies and lessoned learned for identifying potential DURC and the subsequent development of risk mitigation plans. Course participants will review a variety of different experiments, research proposals, data, and manuscripts to determine their potential for DURC. The Instructor will guide course participants through a facilitated discussion to determine the DURC potential of the reviewed material and the risks and benefits of the research. Lastly, the Instructor will lead a discussion where participants develop effect and compliant risk mitigation plans for the proposed research.

OBJECTIVES
Upon completion of this webinar, participants will be able to:

  • Summarize the USG DURC and P3CO Polices
  • Apply current USG DURC Policies to identify potential DURC within their research enterprise
  • Develop and implement DURC risk mitigation plans to effectively manage potential DURC and comply with USG Policies

COURSE FACULTY
Rebecca Moritz, MS, CBSP(ABSA), SM(NRCM), Colorado State University, Fort Collins, CO

SUGGESTED BACKGROUND
Fundamentals of Biosafety, Risk Assessment, Principles and Practices of Biosafety

TARGET AUDIENCE
Experienced Biosafety Professionals, All Safety Professionals

AUDIENCE LEVEL
Intermediate

COURSE LENGTH
4 hours with a 30-minute break

CONTACT HOURS
This course has been approved for .5 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4 P.A.C.E.® contact hours.

13 – Advanced Risk Assessment

November 15 and 18, 2021
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
Upon completion of this webinar, participants will be able to:

  • 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

COURSE FACULTY
Chad Austin, PhD, CBSP(ABSA), SM(NRCM), USDA National Bio and Agro-Defense Facility, Manhattan, KS
Anne-Sophie Brocard, PhD, RBP(ABSA), CBSP(ABSA), University of Texas Medical Branch—Galveston, Galveston, TX
Brandon Hatcher, PhD, RBP(ABSA), CBSP(ABSA), Centers for Disease Control and Prevention, Atlanta, GA
Betsy Weirich, MS, SM(NRCM), CBSP(ABSA), Centers for Disease Control and Prevention, Atlanta, GA

SUGGESTED BACKGROUND
Fundamentals of Biosafety, Microbiology, and Molecular Biology; Basic Risk Assessment, Principles & Practices of Biosafety

TARGET AUDIENCE
Experienced Biosafety Professionals, Laboratory Workers

AUDIENCE LEVEL
Advanced

COURSE LENGTH
8 hours (two 4-hour live sessions with a 30-minute break each session)

CONTACT HOURS
This course has been approved for 1 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8 P.A.C.E.® contact hours.