PROGRAM
ALL PRECONFERENCE COURSES
Preconference Courses
Saturday, October 20, 2012
8:00 am - 5:00 pm
7. Concepts of Virology and Virus-based Gene Vectors
Patrick Condreay, PhD, GlaxoSmithKline R&D, Research Triangle Park, NC
The first section of this course will introduce some concepts of gene expression and review basic virology with a focus on
the characteristics of viral families, viral replication strategies, pathogenesis and persistence, and anti-viral intervention.
The second section will examine gene expression technology and principles of viral vector use before exploring
characteristics of viral systems that are commonly used as gene delivery vectors in biomedical research. The material is
targeted for the biosafety professional who does not actively conduct laboratory research, yet wishes to acquire a basic
knowledge of virology and recombinant viral vectors. Participants should be familiar with molecular biology.
Objectives:
- Express a familiarity with the molecules and communicate the basic processes involved in recombinant gene expression
- Define basic concepts of virology
- Recognize the characteristics of viral systems that are used as gene delivery vehicles
- Apply the knowledge of basic virology and characteristics of viral vector systems to risk assessment of recombinant viruses and protocols involving them
Suggested Background: Risk Assessment, Microbiology and Molecular Biology 101, Principles and Practices of
Biosafety
Target Audience: All Safety Professionals, Experienced Biosafety Professionals
Audience Level: Intermediate
8:00 am - 5:00 pm
8. BSL-3 Operations and Management
Domenica Zimmerman, University of Texas Medical Branch, Galveston, TX
J. Paul Jennette, RBP, Cornell College of Veterinary Medicine, Ithaca, NY
This course will review the important aspects of the daily operation of a BSL-3 facility from two points of view;
management of the facility and daily operations. This assumes that you already have a facility built and have all
required authorizations to work in it. The course will cover the different aspects you need to consider to operate a
BSL-3 facility such as approval of a worker, training of workers and maintenance support, occupational health issues,
managing waste, maintenance of the HVAC and physical facility, periodic checks on the facility's systems, and
emergencies of different types. It will also cover daily operations in a BSL-3 such as understanding when it is safe to
enter and when you need to evacuate the facility, what to do when the ventilation fails, practical aspects of entry and
exit procedures, practical tips on selection and use of PPE, safety considerations within the experimental SOPs, waste
handling, facility's cleaning, and how to have equipment repaired or serviced. The class will be conducted in a way
that allows for interaction and exchange of experiences between participants and instructors. This course will not
cover regulatory aspects from specific countries.
Objectives:
- Describe elements of annual verification, emergency response, etc.
- Recognize institutional responsibilities from management to user
- Describe methods to develop manuals, SOPs, and training
Suggested Background: Basic understanding of risk assessment and biosafety principles
Target Audience: All Safety Professionals
Audience Level: Basic
8:00 am - 5:00 pm
9. Engineering for the Biosafety Professional
Theodore J. Traum, PE, World BioHazTec Corporation, Rockville, MD
Juan Osorio, World BioHazTec Corporation, Rockville, MD
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. The biosafety professional's training and experience is usually limited to the sciences and often lacks the
knowledge of basic engineering principles. This course is intended to provide basic engineering principles that are
useful in the planning, design, maintenance, and certification of containment facilities. The objective of this course is
to equip the biosafety professional with the engineering tools to understand biocontainment planning, design,
construction, maintenance, and operation activities. For the biosafety professional to participate in these activities,
basic knowledge and understanding, development of skills to ask questions in engineering terms and the confidence
to question the answers is needed. The course will provide information relevant to BSL-3 facilities for the
determination of air change rates, interpretation of drawing schematics relating to containment supply and exhaust
systems, an introduction in determining room heat loads and ventilation rates, concepts in directional airflow and
room pressure differentials, ductwork distribution design and components, HEPA filtration, HVAC control issues,
electrical power, lighting, and signal systems. Building on this information, there will be a step-by-step presentation
on planning a laboratory, certification, maintenance, and operation. At the course's conclusion, the participants will
have the knowledge to better understand engineering issues in the design of biocontainment facilities, be able to
formulate informed questions, understand the certification process, be able to interact with maintenance personnel
and integrate facility operations with the biosafety program.
Objectives:
- Recognize engineering issues in the design of biocontainment facilities
- Formulate informed questions in engineering terms and have the confidence to question the answers
- Interact with maintenance personnel and integrate facility operations with the biosafety program
- Explain the certification process
Suggested Background: None
Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, Operations and
Maintenance Personnel
Audience Level: Basic
8:00 am - 5:00 pm
10. Designing Training Programs for a Biosafety Environment
Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM
Lora Grainger, PhD, Sandia National Laboratories, Albuquerque, NM
This course will give participants the insight and basis for tailoring a training program specifically to the hazards and
biorisks for their respective institutions. The focus will be on overcoming the unique challenges involved with
teaching adults including an introduction to the theory and psychology behind effective training for adult learners.
The course will also cover strategies for working with differing levels of preexisting knowledge and educational levels.
Different training methods will be utilized and discussed while addressing learning preferences (visual, auditory, and
kinesthetic) with the purpose of understanding each method. Discussions will be held regarding methods suitable for
large or small groups, learning retention, and the overall usability for the biosafety and biosecurity field. The
instructors will emphasize how a mix of theoretical case studies, incidents, accidents, and other experiences which
will provide a basis for an ongoing, engaging, and interesting training program. The course consists of a mixture of
theoretical lessons and facilitated adult learning using group discussions and presentations giving insight in the
psychological background for how training can either be a success or a failure.
Objectives:
- Express an understanding of why we train and training topic drivers
- Summarize training objectives and training design cycle (Analyze, Design, Develop, Implement, and Evaluate [ADDIE])
- Restate different learning styles (reflector, theorist, pragmatist, and activist), Kolb's Cycle (experience, reflect, model, and practice), and Blooms Taxonomy of Cognitive Domains (know, learn, apply, analyze, and evaluate)
- Differentiate between training, teaching, coaching, and facilitating
- Distinguish the pros and cons for different teaching styles and the costs and resources needed for different types of training programs
- Determine the suitability of different training methods for different types of staff/employees depending on skills, education, personality type, and learning preference
Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals, Experienced Biosafety Professionals
Audience Level: Basic/Intermediate
8:00 am - 12:00 pm
11. Case Studies in Recombinant DNA and Dual Use Research
Kathryn Harris, PhD, RBP, National Institutes of Health, Bethesda, MD
In this interactive session, participants will have an opportunity to work through a series of case studies describing
hypothetical events occurring in the course of recombinant DNA research that might represent significant problems
or violations that need to be addressed and corrected by the institution. After discussion of the initial scenario,
participants will be led through a process where they will contribute their own facts and ideas to create a dynamic
case study experience. A similar process will be used to examine the institutional oversight and management issues
posed by life sciences research that is potentially a dual use research of concern.
Objectives:
- Describe institutional responsibilities for ensuring the safe conduct of recombinant DNA research
- Recognize the need for oversight, management, and responsible conduct of dual use life sciences research
- Describe the importance of developing institutional biosafety and biosecurity polices and a robust training program
Suggested Background: Basic knowledge of NIH Guidelines for research involving rDNA
Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, IBC Chairs, IBC
Members, other staff supporting the IBC, Research Oversight and Compliance Officials
Audience Level: Intermediate
8:00 am - 12:00 pm
12. Microbiology and Indoor Air Quality
Jyl Burgener, RBP, CBSP, Grifols, Clayton, NC
The purpose of this course is to acquaint the participant with a basic understanding of the role of microbiology in
indoor air quality (IAQ) investigations.
Objectives:
- Restate the differences between Sick Building Syndrome, Building Related Illness, and Crisis Building
- Define the typical medical symptoms associated with Sick Building Syndrome and Building Related Illness
- Identify common causes or origins of IAQ complaints
- List various types of environmental conditions that lead to bacteria or mold amplification
- Review some sampling strategies for documenting the presence or absence of mold in an environment
- Cite concerns and the how to mitigate occupational exposure during mold remediation activities
Suggested Background: Background in microbiology and some experience performing IAQ investigations
Target Audience: All Safety Professionals, New Biosafety Professionals
Audience Level: Intermediate
8:00 am - 12:00 pm
13. Introduction to a Nonhuman Primate Training Program
Belinda Rivera, University of Texas Medical Branch, Galveston, TX
This course will introduce basic information to individuals that are currently working or plan on working with
nonhuman primates (NHP) in their institutions. This course can also be used to evaluate an existing NHP training
program or assist in developing a new program. Topics will include personal protective equipment (PPE), Herpes B
risk assessment, emergency procedures, training of personnel, and documentation of training. Training of personnel
should be based on an individual's job requirement which may include direct or indirect contact with NHPs and
training documentation requirements needed to fulfill institutional and regulatory agencies. Other topics that will be
discussed include NHP behavior, handling of NHPs, common technical procedures performed on NHPs and
regulations regarding their caging and enrichment requirements. At the conclusion of the course, case-based
scenarios will be used to illustrate key points.
Objectives:
- Evaluate existing NHP training program or be able to implement a new program
- Determine a risk assessment based on a person's required training
- Summarize a Herpes B risk assessment
- Determine proper PPE for personnel working in NHP rooms
- Apply knowledge gained regarding an emergency/exposure response
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Animal Caretakers
Audience Level: Basic
8:00 am - 12:00 pm
14. Infectious Substance Shipping Refresher Course
Eric Cook, MPH, CBSP, Sandia National Laboratories, Albuquerque, NM
This course is intended for those who are already experienced dangerous goods shippers. Those who wish to
participate in this course must have completed an IATA Dangerous Goods certification course within the past 3 years.
Participants will receive an update of changes to U.S. and international regulations that affect shippers of infectious
substances. The course will provide a brief review of applicable regulations, shipper's responsibilities and overview of
the nine classes; detailed analysis and discussion of infectious substance classification, Category A, Category B, and
exempt materials; packaging, marking, and labeling infectious substance shipments including dry ice and liquid
nitrogen shipments; and practical exercises regarding the essentials of applicable documentation. This is a refresher
course for those need recertification. A certification exam will be given at the conclusion of the course. Participants
must score at least 70% in order to be certified.
Objectives:
- Cite relevant changes and review both U.S. and international regulations affecting shippers of infectious substances
- Explain how to properly classify infectious substance shipments (Category A, Category B, exempt, and materials excepted from the regulations)
- Summarize how to properly package, mark, label, and prepare shipments of infectious substances, Category A, Category B, and exempt (including over packs, dry ice, and liquid nitrogen)
- Review how to complete paperwork associated with infectious substance shipping (shipper's declaration, airway bill, etc.)
Suggested Background: Completed IATA certification (or other relevant) course within the past 3 years
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, those needing IATA
recertification
Audience Level: Advanced
1:00 - 5:00 pm
15. NIH OBA and Select Agent Incident Reporting: A Practical Guide
Bruce Whitney, PhD, Texas A&M, College Station, TX
This course is designed to assist biological safety officers and administrators/management in the process of reporting
incidents under the NIH Guidelines for research involving recombinant DNA molecules (NIH Guidelines) and the
select agent regulations. This course will not only review the regulatory requirements and process for reporting, but
will offer practical guidance for incident investigation (including the root cause analysis) and writing both immediate
and follow-up incident reports. The course will be highly interactive and end with real-world scenario-based
exercises. Participants are encouraged to bring their own scenarios for discussion and practice.
Objectives:
- Explain federal reporting requirements and process
- Identify incidents that require reporting and those that do not
- Apply root cause analysis in the incident investigation process
- Write immediate and follow-up incident reports for submission to federal regulators
Suggested Background: None
Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals,
Administrators/Management
Audience Level: Basic
1:00 - 5:00 pm
16. Biorisk Management Systems—Developing Your Roadmap to Implementation
Patricia Olinger, RBP, Emory University, Atlanta, GA
This course is an introduction to Biorisk Management Systems. The class will use the elements of CWA 15793:2008
and its guidance document CWA 16363:2012 to provide participants with a better understanding of what is needed to
develop their own road map to biorisk management program development and implementation.
Objectives:
- Communicate the elements of a biorisk management systems
- Describe the elements of a management system and how they are used to develop road map to implementation
- Identify measures and metrics for program effectiveness
Suggested Background: None
Target Audience: Experienced Biosafety Professionals, All Safety Professionals
Audience Level: Intermediate
1:00 - 5:00 pm
17. Aerobiology in Infectious Disease Research: Fundamental and Applied Concepts
Chad Roy, PhD, Tulane University, New Orleans, LA
This course is intended to introduce the fundamental concepts of aerobiology and applications in infectious disease
research. The major scientific tools and laboratory procedures associated with this activity will be presented
didactically. Discussions will include the integration of animal exposure in the context of biomedical research and the
implications for working safely in high-containment environments. Introduction of these specialized techniques and
the use of major engineering controls used in this type of research (Class III biological safety cabinet) in conjunction
with many of the common inhalation configurations used in this type of research. The overarching goal of this course
is to leave the participants with an appreciation and general working knowledge of the major components and
associated laboratory technique in facilities engaged in infectious disease research which also house the capability to
perform studies that incorporate aerobiology.
Objectives:
- Identify the major scientific tools and engineering controls used in this type of research
- Recognize the nature of laboratory-generated aerosols containing highly infectious agents and their consequences
- Restate requirements for operational safety and health in work environments that include this
- Recognize of the health and safety implications of the integration of live animal experimental exposures with infectious aerosols under high-containment
Suggested Background: Fundamentals of Biosafety, Biosafety Level 3 Operations
Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, Laboratory Workers
Audience Level: Intermediate
1:00 - 5:00 pm
18. Biological Toxins and the Biosafety Professional
Andrew Maksymowych, PhD, RBP, University of Pennsylvania, Philadelphia, PA
Susan Souder, CBSP, University of Pennsylvania, Philadelphia, PA
Toxins of biological origin are routinely used in many research laboratories. Providing appropriate guidance
regarding safety practices to a researcher working with a biological toxin may not feel like a straightforward matter. A
number of variables must be evaluated in order to provide appropriate guidance. Answers need to be articulated
regarding what kind of biological toxin is being used, the potential routes of exposure, and a risk assessment specific
to the work being pursued. (Topics covered include identifying select agents, safety measures for working with
animals, shipping guidelines and communication of safety handling criteria.) Resources for developing an adequate
risk assessment will be discussed. This interactive course will provide an opportunity to integrate basic knowledge
and practical skills for recommending safe work practices when using biological toxins. Using sample scenarios and
hands-on exercises participants will evaluate and apply the information presented by working together in groups
conducting risk assessments, evaluating case studies, and sharing their results. This activity will provide participants
the basic tools to communicate safe work practices to researchers.
Objectives:
- Describe the general properties of biological toxins
- Outline proper resources and guidance to enable safe work with biological toxins
- Perform a risk assessment for working with a biological toxin
- Identify and address common misconceptions regarding work with biological toxins
- Summarize case studies regarding working with a biological toxin
Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals, Experienced Biosafety Professionals
Audience Level: Intermediate