63rd Annual Biosafety and Biosecurity Virtual Conference

Professional Development Courses

October, 2020

Professional Development Courses |
Scientific Program

3 – Infectious Substance Shipping Certification

Monday – Friday, October 5-9, 2020
This course is appropriate for those who have some experience with infectious substance handling or shipping, but may not have been certified within the past 3 years. Group discussions and interactive exercises focused on the essential areas of infectious substance shipping will be utilized. Participants will mark, label, package, and complete documentation for infectious substances shipments (Category A, Category B, and Exempt Patient Specimens), and review applicable regulations with a focus on IATA. 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 a written 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 principles of infectious materials
  • Demonstrate how to package, mark, label, and document shipments for infectious substances, Category A, Category B, and dry ice
  • Pass a final written exam for IATA/DOT shipper certification requirements

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

6 – Introduction to Biosafety in the Clinical Setting

October 7, 2020
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, Research Administrators, Clinical Professionals

4 – Animal Research for Biosafety Professionals—Part I

October 12, 2020
Animal research has contributed to major scientific advances in biomedical, veterinary, public health, and environmental sciences. 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, requiring 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 programs that utilize rodents, small animals, and agricultural species, with a primary focus on identifying and managing biological, chemical, radiological, and physical hazards. The instructors are experienced laboratory animal veterinarians, actively involved in the management, oversight, and evaluation of animal care and use programs. Course 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. Interactive group activities and problem-solving sessions will engage participants to apply their new knowledge and skills.

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

SUGGESTED BACKGROUND
None

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

9 – Select Agent Inactivation: A Practical Guide for the Biosafety Professional

October 14, 2020
This course is intended to provide biosafety professionals with a strong foundation and practical knowledge of select agent inactivation which will directly benefit them in carrying out their responsibilities as the RO, ARO and/or BSO. Each of the didactic modules will be followed by relevant hands-on exercises carried out in small groups. The course introduces the current regulatory requirements of select agent inactivation, regulatory interpretations, guidance from the Federal Select Agent Program, and strategies from entities for compliance. This course will not discuss large-scale inactivation as it relates to pharmaceutical products; it will focus specifically on select agents that are inactivated to be used at a lower biocontainment level. Participants will review an inactivation SOP and associated validation data, formulate and “request” additional information from the Principal Investigator (PI), and “take” the documents to committee on behalf of the PI for review, critically review data with the committee, formulate feedback to the PI, and facilitate approval. Through a facilitated discussions, participants will be lead to the development of a standard operating procedures (SOPs) for executing all of the above discussed processes and mechanisms for documenting compliance pre- and post-approval.

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

  • Identify and analyze current regulatory requirements, regulatory interpretations, and guidance documents from authoritative sources
  • Summarize the mechanisms of inactivation that be might encountered during review of such requests
  • Choose the appropriate strategies for managing and documenting select agent inactivation requirements

COURSE FACULTY
Antony Schwartz, PhD, CBSP(ABSA), SM(NRCM), Duke University, Durham, NC

SUGGESTED BACKGROUND
Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles & Practices of Biosafety, Select Agents

TARGET AUDIENCE
All Biosafety Professionals, Responsible Officials, Alternate Responsible Officials

AUDIENCE LEVEL
Intermediate

10 – Biorisk Communications: Tailoring Information for Diverse Institutional Stakeholders

October 14 and October 15, 2020
Risk communications are an essential element of the risk assessment and risk management cycle. The objectives of biorisk communications are to engage stakeholders in a 2-way flow of information that facilitates active listening as well as messaging; empower decision-making by providing stakeholders with contextual information on risks, resources, and options for action; and evaluate the impact of biorisk awareness-building and training strategies to identify potential areas for improvement. This course is aimed at helping biosafety/biosecurity professionals and researchers understand the principles of risk communications and how they can be used to strengthen institutional biorisk management programs. Through case studies, interactive discussions, and dynamic brainstorming activities, participants will develop key messages and an action plan for tiering appropriate biorisk messages to institutional stakeholders (e.g., senior decision makers, safety and health officials, senior investigators, laboratory professionals, participants and other trainees, and support staff), and evaluating the impact of biorisk communications on individual and institutional behaviors.

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

  • Describe risk communications principles, strategies, and tools that can be applied effectively to strengthen institutional biorisk management programs
  • Compare biorisk management objectives for institutional stakeholders with different capabilities, roles and responsibilities, and access needs
  • Develop draft messages and an action plan that can be used to design a tiered biorisk communications approach for an institution, including strategies for measuring impact on awareness, knowledge, and practices

COURSE FACULTY
Julie Fischer, PhD, Elizabeth R. Griffin Program, Georgetown University Medical Center, Washington, DC
Erin Sorrell, PhD, Georgetown University, Washington, DC
Claire Standley, PhD, Georgetown University, Washington, DC

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers

AUDIENCE LEVEL
Intermediate

11 – Managing the Potential for Human Failure Through Biosafety Critical Task Analysis

October 15, 2020
Human failure is cited as being directly responsible for up to 80% of accidents. In the high-hazard biological research and diagnostics sector, human failure can lead to loss of containment of a pathogen and potential exposure of personnel or release to the environment. It is important to understand how and why human failure occurs, and how it can be prevented or managed. This course will introduce participants to a qualitative methodology for analyzing biosafety critical tasks in order to identify the potential for human failure and ways to prevent such failure or mitigate its consequences. Participants will be guided through the breakdown of a biosafety critical task into its component steps (task analysis), to the identification of potential for human failure at each stage. Types of human failure and the factors that make failures more likely (performance influencing factors), and engineering and procedural controls to reduce the likelihood of each type of human failure will be discussed.

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

  • Explain, using examples, the types of human failure that lead to incidents
  • Perform a basic biosafety critical task analysis and identify potential human failures at each stage
  • Propose ways to prevent or reduce the likelihood of the human failures identified and to mitigate the consequences should the failures occur

COURSE FACULTY
Anna Lawton, CMIOSH, The Pirbright Institute, Woking, United Kingdom
Graeme Harkess, MSc, MRSB, The Pirbright Institute, Woking, United Kingdom

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, All Biosafety Professionals

AUDIENCE LEVEL
Intermediate

5 – Institutional Biosafety and Biosecurity—The Basics of Oversight

October 16, 2020
This course will discuss the function and administration of Institutional Biosafety Committees (IBCs) and Institutional Review Entities (IREs). Developed and taught by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP), this course will promote the professional development of those associated with IBCs and IREs by providing an opportunity to learn about: the NIH OSP and the biosafety and biosecurity oversight framework in the U.S.; the content of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); the U.S. Policies for Oversight of Dual Use Research of Concern (DURC); and the roles and responsibilities that IBCs and IREs have in the biosafety and biosecurity oversight of life sciences research at the institutional level. This course provides an introductory level overview and may be helpful for those new to the field or for those who are interested in the Institutional Biosafety and Biosecurity Oversight Governance workshop.

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

  • Restate the requirements of the NIH Guidelines
  • Recall the requirements of the U.S. Government Policies for Oversight of Dual Use Research of Concern (DURC)
  • Describe the the roles and responsibilities of IBCs and IREs as a key part of the biosafety and biosecurity oversight of life sciences research

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

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
New Biosafety Professionals, IBC and IRE Members and Staff

12 – Advanced Topics in Plant Research for Biosafety Professionals: Hazard Identification, Risk Assessment and Much More

October 19, 2020
The use of genetic modification in the modern agriculture industry plays a critical role in helping farmers provide a safe, abundant supply of our food, feed, and fuel. Understanding this tool, the regulations around its use, and the safety requirements in place to minimize risk and identify hazards is important for both safety professionals and plant program personnel. This course will provide participants with an overview of APHIS permits including Plant Protection & Quarantine (PPQ), Biotechnology Regulatory Service (BRS) Veterinarian Services (VS), and the NIH Guidelines as it relates to environmental release and financial loss. A variety of advanced scenarios and interactive exercises to demonstrate the range of biological, genetic modification, and the risks and hazards routinely encountered in the greenhouse, fields and labs supporting plant research will be discussed. 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 permit requirements, hazard identification, and risk assessment techniques as they apply to research involving genetically modified (GM) plants
  • Recognize how to incorporate effective hazard and exposure control strategies into GM and arthropod lab and 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 Corporation, Durham, NC
Kirt Poulsen, Utah State University, Logan, UT

SUGGESTED BACKGROUND
Risk Assessment, Basic understanding of plant biology, genetically modified and breeding applications

TARGET AUDIENCE
All Safety Professionals, All Biosafety Professionals

AUDIENCE LEVEL
Advanced

1 – Basic Risk Assessment

October 23, 2020
Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the practices and containment necessary to avoid exposure to hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary to perform risk assessments for working safely with pathogens (human and animal) and rDNA (genetically modified organisms or viral vectors). Using case studies, participants will work together to conduct risk assessments by determining the hazards involved; the appropriate questions to ask to address the potential risks associated with the intended activities; and make recommendations on appropriate containment and practices required to work safely. Each group will present their conclusions of the activity.

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

  • Identify and list determinants for assessing risk (host, environment, agent)
  • Complete the steps of a risk assessment and determine steps to manage risk (mitigation)
  • Identify resources and references for risk assessment/management

COURSE FACULTY
Chad Austin, PhD, CBSP(ABSA), SM(NRCM), National Bio and Agro-Defense Facility, U.S. Department of Agriculture, 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), Booz Allen Hamilton, Atlanta, GA
Elizabeth Weirich, MS, CBSP(ABSA), SM(NRCM), Centers for Disease Control and Prevention, Atlanta, GA

SUGGESTED BACKGROUND
Fundamentals of Biosafety

TARGET AUDIENCE
New Biosafety Professionals, Laboratory Workers

AUDIENCE LEVEL
Basic

7 – Introduction to the ISO 35001: Biorisk Management for Laboratories and Other Related Organizations

October 23 and 30, 2020
There is an international demand for a stringent and robust system for handling risks of biological materials. 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 the 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 ISO 35001 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 begin with an introduction to the ISO 35001 followed by a brief introduction to the major sections including leadership, planning, support, operation, performance evaluation and improvement, and subsequently discussions about how to initiate implementation to improve a biorisk management system. Through facilitated discussions and activities, participants will have 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 ISO 35001 certification.

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

  • Recall the sections of ISO 35001 and its requirements as an international standard for laboratory biorisk management
  • Identify how to use ISO 35001 to initiate an improvement plan for an overall lab biorisk management system
  • Plan a process to analyze and improve an existing biorisk management system to qualify for ISO 35001 certification

COURSE FACULTY
Eric Cook, MPH, CBSP(ABSA), Sandia National Laboratories, Albuquerque, NM
Rawan Khasawneh, MSc, Jordan University of Science and Technol, Irbid, Jordan
Kalpana Rengarajan should be PhD, MPH, JM, RBP(ABSA), Emory University, Atlanta, GA

SUGGESTED BACKGROUND
Fundamentals of Biosafety

TARGET AUDIENCE
All Safety Professionals, New Biosafety Professionals, International ABSA Members

2 – Basic Threat Assessment for Laboratory Biosecurity Programs

October 27, 2020
This awareness course will teach biological and biomedical laboratory administration, management, and researchers the basic principles of threat assessment. Participants will be introduced to the role of threat assessment in laboratory biosecurity programs. Content provided will create a basic tool-kit for participants to implement successful insider threat mitigation strategies using threat assessment approaches and convey concepts in threat assessment to their colleagues. The course will follow established criminal psychology techniques in the personal protection field used to identify, assess, and manage dangerous threats. Participants will view relevant case studies to learn about basic threat indicators, approaches to make threats, and threatening behaviors. Through analysis of relevant case studies, participants recognize specific personal security vulnerabilities and how to link these vulnerabilities to threats. The course will focus on the purposes and requirements of biosecurity programs, the role of threat assessment in the management of effective personal security, and personal suitability or reliability components of biosecurity programs. Regulatory issues relevant to threat assessment and to the implementation of personnel management programs, in particular changes to the Select Agent Regulations pertaining to Tier 1 agents, will also be discussed. Theoretical concepts will be put into practice in a 3-hour tabletop exercise devised around 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:

  • can be implemented in a successful insider threat mitigation program
  • Recognize specific personal security vulnerabilities and how to link these vulnerabilities to threats
  • Restate the purpose and requirements of basic suitability or reliability and threat assessment programs and their roles in laboratory biosecurity management

COURSE FACULTY
Lindsay Odell, PhD, US Army Reserve, Washington, DC
Ben Perman, PhD, RBP(ABSA), United States Coast Guard, Alexandria, VA

SUGGESTED BACKGROUND
None

TARGET AUDIENCE
All Safety Professionals, Laboratory Workers, First Responders, Security Professionals

AUDIENCE LEVEL
Basic

8 – Engineering for the Biosafety Professional—Part II

October 29, 2020
Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance and certification of their containment facilities and building systems. Frequently, the biosafety professional is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course provides basic engineering principles that are useful in the planning, design, construction, maintenance and operation of a BSL-3 or high-containment facility. The principles are expanded to BSL-4 or maximum containment facilities for clarity between BSL-3 and BSL-4 requirements. To participate in these activities, the biosafety professional will need a foundation of engineering fundamentals, to develop skills to ask questions in engineering terms, and the confidence to question the answers. Topics covered include interpreting architectural and engineering drawings including plan views, personnel and waste flows, scaling, calculating air changes, and an in-depth review of HVAC drawings, airflow reversal mitigation, and engineering redundancies. There will be a review of commissioning and certification processes, including elements of ventilation assessment. Individual and group exercises will be conducted for practical application of principles presented. Building on “Engineering for the Biosafety Professional—Part I,” this course will integrate examples that show cause and effect in real-life scenarios.

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

  • Discuss engineering principles
  • Apply engineering assessment tools for architectural and engineering drawings
  • Evaluate engineering solutions
  • Describe the BSL-3 laboratory commissioning and certification processes

COURSE FACULTY
Juan Osorio, IE, World BioHazTec Corporation, North Bethesda, MD
Ted Traum, PE, CCP, DGCP, World BioHazTec Corporation, North Bethesda, MD

SUGGESTED BACKGROUND
Fundamentals of Biosafety, Engineering for the Biosafety Professional—Part I (preferred)

TARGET AUDIENCE
All Safety Professionals, New Biosafety Professionals, Facilities Professionals

AUDIENCE LEVEL
Intermediate