Preconference Courses
Sunday, October 30, 2011
1:00 - 5:00 pm
24. The Physics Behind Biocontainment
Juan Osorio, National Institutes of Health, Bethesda, MD
Theodore J. Traum, PE, World BioHazTec Corp., Rio Rancho, NM
Diego Osorio, National Biosafety and Biocontainment Training Program, Bethesda, MD
Many principles in physics can be applied to the proper operation of a biocontainment laboratory. Concepts such as directional airflow, pressure, temperature, and humidity are needed to make a biocontainment facility run effectively and efficiently. Some biosafety professionals may not be aware that these concepts can impact their work and research. The objective of this course is to explain physics concepts using basic, real-life examples and ultimately relate these concepts to how they apply to biocontainment laboratories. Throughout the course, examples of basic physics concepts will be demonstrated to add a visual dimension that formulas and definitions cannot accomplish. Physics visual aids will be used to demonstrate actual engineering principles relating to biocontainment laboratories.
A hands-on activity will be conducted following the explanation of each physics concept. This course will not be driven by formulas but will integrate examples that show cause and effect in real-life scenarios. Building on this information, there will be a step-by-step presentation on how these examples are relevant to planning a laboratory, validation, certification, maintenance, and operation.
Objectives:
- Understand how physics affects the planning, design, maintenance, operation, and certification of a biocontainment facility
- Apply physics concepts and formulas to control variables that impact daily work and eliminate disruption
- Interpret and understand data used for measuring pressure, temperature, humidity, and airflow
- Recognize how a building's system is affected by variables such as barometric pressure and temperature
Suggested Background: None
Target Audience: All safety professionals
Audience Level: Intermediate
8:00 am - 5:00 pm
25. Preparing for, Conducting, and Responding to Regulatory Agency Inspections/Audits
Barbara Fox Nellis, SM(NRCM), RBP, CBSP, Barb Nellis Consulting, Sarasota, FL
Christina Thompson, RBP, CBSP, Thompson Biosafety, LLC, Greenfield, IN
This course will prepare the biosafety and other safety professionals; the entity and laboratories for onsite regulatory inspections. The general outline consists of the following components: Background—what are the different regulators looking for and what do they want in advance of their visit, if it is announced; what to do with a surprise inspection depending upon inspection agency. How do the onsite audits vary and what is similar between CDC, USDA, DHS, DOD, DOT, FAA, NIH, DEA, and other regulatory agencies. Preparation—steps to take in preparing the facility, documentation and personnel as well as the management team for the onsite audit. Recommendations have been tested in numerous audits and have worked well. Why OSHA regulation compliance and training records are important. How to conduct yourself during the audit—what you can and should control and tips for training the visiting auditors if they expect to enter hazardous chemical, biological, or radiation areas. Worker interviews and stumbling blocks, training records and verification of training, individual training records for various work and containment environments. The opening and closing meetings—what should the auditors present and what should your facility present. The follow-up report—how to word this, presenting timelines for completion and thoughtful challenges to the auditor's finding. Case studies will be completed in a small group break-out, checklists used by the various regulatory agencies will be shared, and internal checklists for the facility created from templates to cover various types of facilities.
Objectives:
- Understand what agencies can and will inspect your entity
- Be prepared with the proper documentation and training
- Identify the follow-up that is required and the level of detail that is necessary
Suggested Background: Fundamentals of Biosafety
Target Audience: All safety professionals
Audience Level: Basic/Intermediate
8:00 am - 5:00 pm
26. Biorisk Assessment of Emergency Scenarios
Paul J. Huntly, Det Norske Veritas Pte Ltd., Singapore
The course will present an overview of issues surrounding the principles required for effectively understanding and controlling risks associated with potential emergency scenarios in containment laboratories. Sessions will be split between presentations of discussions around when formal risk assessments should be conducted, simple risk assessment philosophies and models, and interactive group exercises discussing the practical challenges in relation to what are the real vs. perceived risks in such situations, together with what may constitute reasonable and proportionate mitigation measures. Information, examples, and scenarios will be drawn from a wide experience of conducting risk assessments and audits in a wide range of facilities around the world. The aim will be not only to inform, but to stimulate discussion and challenge participants to question the realities of such situations, by considering risk holistically from a very practical perspective. The course will be of interest to those involved in day to day managers/supervisors of laboratories, but also to regulators and those responsible for planning, emergency response, etc.
Objectives:
- Understand some basic structures and philosophies of risk assessment as applied to emergency planning
- Develop an awareness of the range of emergency scenarios that may be encountered and how these can be assessed, plans can be developed and tested
- Gain an increased awareness that emergency situations are complex and difficult to manage, requiring basic planning based around the need to be able to reliably respond in a practical and logical manner
- Share experiences and views in relation to emergency situations and discuss different stakeholder risk perceptions and how these can impact on our ability to respond effectively
Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All safety professionals, laboratory workers, animal caregivers
Audience Level: Intermediate/Advanced
8:00 am - 5:00 pm
27. Basic Building Blocks of Biosafety
Benjamin Fontes, MPH, CBSP, Yale University, New Haven, CT
This course is not a formal introduction to biological safety, but is a course that will provide guidance for and review approaches to performing many of the core job responsibilities of the modern biosafety professional whose primary responsibilities are in the research setting (although many of the approaches demonstrated can be applied to other domains). The course has been developed for new biosafety professionals who are looking for ideas, suggestions, tips, approaches, sample forms, checklists, and even sample training slides as starting points to initiate their own approaches in their host locations. This is a "how to" class for "can do" students and the goal is to help show participants some successful approaches to performing the central duties of biosafety officers in research settings. This 8-hour class will focus on how to: 1) create registration forms for projects involving biohazards, including pathogens, rDNA, human materials, and other biohazards; 2) prepare for, conduct, report and follow-up on a biosafety laboratory inspection; 3) prepare and present basic biosafety training classes and obtain student feedback; 4) assist with the review, risk assessment, and development of safety plans for protocols involving biohazards in lab settings and for protocols involving small conventional research animals; 5) review rDNA protocols for compliance with the NIH rDNA Guidelines; 6) how to carry-out the biosafety officer's roles and responsibilities associated with the Institutional Biosafety Committee; and 7) the class will only provide a starting "glimpse" at BSL-3 program elements, with a focus on what resources are available for assistance with inspections, facility validation and training both within and outside of their institutions.
Objectives:
- Give direct examples of how to apply baseline biosafety knowledge to real-life situations in the field
- Conduct laboratory inspections
- Review protocols for work with biohazards
- Prepare and conduct biosafety training classes
Suggested Background: Fundamentals of Biosafety
Target Audience: New biosafety professionals
Audience Level: Basic/Intermediate
8:00 am - 12:00 pm
28. Viral Vector Technology and Risk Assessment
Dawn Wooley, RBP, CBSP, Wright State University, Dayton, OH
A half-day course on the basics of viral vectors, safety considerations for working with viral vectors in the research studies, and points to consider for institutional review of viral vector protocols.
Objectives:
- Use and understand the basic vocabulary of viral vector technology
- Explain different types of viral gene delivery systems
- Identify potential hazards associated with viral vectors
- Describe methods of regulating gene expression
Suggested Background: Microbiology/Molecular Biology 101
Target Audience: All safety professionals, laboratory workers
Audience Level: Basic
1:00 - 5:00 pm
29. Law Enforcement Perspectives on Biosecurity: Prevention Through Partnerships
Edward You, Federal Bureau of Investigation, Washington, DC
William So, Federal Bureau of Investigation, Washington, DC
This course will provide administration, management, researchers, and students a law enforcement perspective of biosecurity and introduce key law enforcement programs that address incident prevention and response including: preparedness, countermeasures, investigations and operations, and intelligence. Students will learn about the Biological Weapons and Toxins Statute (18 USC 175) and how it serves as a basis for law enforcement. Students will be introduced to various communication strategies that can be used to foster responsibility in their community by enhancing trust and cooperation between scientific, public health, clinical communities, and the law enforcement agencies that serve them. Finally, students will put these concepts to practice in 2 small-scale, tabletop exercises that illustrate the challenges investigators face when responding to an incident at a biomedical research or treatment facility.
Objectives:
- Understand biosecurity roles and responsibilities of law enforcement agencies and research/public health institutes
- Recognize benefits and potential obstacles to improve cooperation among law enforcement agencies and research institutions regarding biosecurity
- Identify regulatory and statutory authorities of the U.S. biological threat prevention strategy and identify the public safety and investigative agencies that can be brought to bear in assessing a threat or responding to an incident
- Understand the authority and jurisdiction of key local, state, and federal law enforcement and public health stakeholders
Suggested Background: None
Target Audience: All safety professionals
Audience Level: Basic/Intermediate/Advanced
8:00 am - 5:00 pm
30. Biosafety Training
Per Staugaard, RBP, Biosafety Training and Consultancy, Utrecht, Netherlands
Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM
This course is intended to provide a basis to set-up a training and qualification program in connection with activities involving biohazards. After an introduction to training in general and more specifically to education, knowledge, and experience, the trainees will set-up a training program in small groups for an imaginary workplace. Specific attention is paid to different training methods and to evaluation of training. Many training methods/tools will be used and practiced.
Objectives:
- Have an overview of different training methods and tools
- Combine the training methods in making a training program
- How to give feedback with the aid of video segments
Suggested Background: None
Target Audience: All safety professionals
Audience Level: Basic/Intermediate/Advanced
8:00 am - 5:00 pm
31. How to Develop an Export Management and Compliance Program Including the I-129 Attestation for Deemed Exports
Deborah Howard, CBSP, University of North Carolina, Chapel Hill, NC
How are you handling the certification regarding the Release of Controlled Technology or Technical Data to Foreign Persons in the United States? Learn about the Fundamental Research Exclusion and the impact Deemed Exports have on your organization. Learn to understand the 6 Terms of Use as it relates to foreign nationals in the workplace. You've been trained to ship hazardous materials according to the IATA/DOT regulations; but did you know many viruses, bacteria, and genetic elements of these pathogens require you to apply for an export control license through the Department of Commerce? All Select Agents and their genetic elements as well as several other recognized pathogens require a license to export. Did you know that items shipped out of the U.S. costing more than $2,500 need to be filed with the U.S. Census Bureau? This class is intended for professionals who manage the shipping/exporting program including Deemed Exports at their university. There is more to shipping than classification, labeling, and marking; there are licensing, under-invoicing, and ITN numbers from the U.S. Census Bureau to consider when shipping anywhere outside the U.S. including Puerto Rico. Join us to learn about the SNAP-R program, Visual Compliance and how the International Traffic and Arms (ITAR) regulations fit into exporting. Troublesome clauses in contracts will also be covered. The class 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:
- Describe the exporting agencies and what items/technology they regulate
- Recommend strategies for implementing an export management plan
- Discuss the I-129 Deemed Export Attestation and how it affects your organization
- Recognize situations where export controls will apply
Suggested Background: None
Target Audience: None
Audience Level: None
1:00 - 5:00 pm
32. Leadership Tools for Today's Biosafety Professional
Jim Welch, Elizabeth R. Griffin Research Foundation, Kingsport, TN
Sean G. Kaufman, MPH, CHES, CPH, Emory University, Atlanta, GA
LouAnn Burnett, CBSP, Sandia National Laboratories, Albuquerque, NM
Caryl Griffin, MSN, MDiv, Elizabeth R. Griffin Research Foundation, Kingsport, TN
Robert Ellis, PhD, CBSP, Colorado State University, Fort Collins, CO
Joseph Kozlovac, RBP, CBSP, United States Department of Agriculture, Beltsville, MD
Edward Stygar, III, MBA, CAE, American Biological Safety Association, Mundelein, IL
This 4-hour course is based on the 3-day ABSA/ERGRF Leadership Institute that is designed to foster and improve leadership skills amongst biosafety practitioners. The 3-day program, designed and led by Sean Kaufman of Emory University, combines presentations from recognized professionals with mentoring and network sessions that explore both common and unique problems. To familiarize ABSA members with Leadership and the Leadership Institute, the course will feature presentations from leaders in biosafety that will offer their different perspectives, experiences, and knowledge to be an effective leader in biosafety. This course will also offer an interactive mentoring session so participants can discuss issues with leaders and other participants.
Objectives:
- Be familiar with principles of effective leadership
- Understand the importance of leadership in biosafety
- Realize the need for leaders at all levels of biosafety
Suggested Background: None
Target Audience: None
Audience Level: None