Fri., Oct. 9, 2015 – Preconference Courses 2015-09-17T13:00:10+00:00
Saturday Preconference Courses[icon url=”/151010precon/” icon=”0231.png”][/icon]

 

[icon icon=”0273.png”]Presenter Bios available where indicated.[/icon]

 
[agenda]
[day date=”9 October 2015″]Friday, October 9, 2015[/day]

[event time=”8am-5pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 05:00 PMAmerica/New_York1. Building a Select Agent Program: Safety, Compliance, and EfficiencyA successful Select Agent Program depends on ensuring personnel safety and maintaining regulatory compliance in an efficient manner. In the absence of efficiency, research can be unnecessarily hindered and regulatory compliance may become overly burdensome, which could lead to lapses that affect the success or failure of an entity’s Select Agent Program. This course will explore strategies for implementing a successful Select Agent and/or Tier 1 Select Agent Program based upon the instructors’ experience with their institution’s Select Agent (including Tier 1) BSL-3 Program. Topics will include identifying site-specific needs; developing and reviewing plans and SOPs; promoting a safety and compliance culture; organizing and tracking inventory; training methods and recordkeeping; providing effective oversight; and preparing for, facilitating, and responding to inspections. Strategies presented will focus on organization, resource management, flexibility, and efficiency. This course will consist of presentations, group discussions, and exercises to assist participants in applying the strategies to the needs of their entities.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

1. Building a Select Agent Program: Safety, Compliance, and Efficiency
Amy Vogler, PhD, RBP, Northern Arizona University, Flagstaff, AZ; Shelley Jones, MS, RBP, Northern Arizona University, Flagstaff, AZ
A successful Select Agent Program depends on ensuring personnel safety and maintaining regulatory compliance in an efficient manner. In the absence of efficiency, research can be unnecessarily hindered and regulatory compliance may become overly burdensome, which could lead to lapses that affect the success or failure of an entity’s Select Agent Program. This course will explore strategies for implementing a successful Select Agent and/or Tier 1 Select Agent Program based upon the instructors’ experience with their institution’s Select Agent (including Tier 1) BSL-3 Program. Topics will include identifying site-specific needs; developing and reviewing plans and SOPs; promoting a safety and compliance culture; organizing and tracking inventory; training methods and recordkeeping; providing effective oversight; and preparing for, facilitating, and responding to inspections. Strategies presented will focus on organization, resource management, flexibility, and efficiency. This course will consist of presentations, group discussions, and exercises to assist participants in applying the strategies to the needs of their entities.

Objectives:

  • Evaluate site-specific needs and expectations
  • Design and implement effective and efficient policies, plans, and procedures compliant with the current CDC/USDA Select Agent Regulations
  • Identify strategies for streamlining and integrating required documentation
  • Describe inventory management techniques to ensure current and accurate inventory records

Suggested Background: None
Target Audience: Safety Professionals dealing with Select Agent Programs
Audience Level: Basic
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[event time=”8am-5pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 05:00 PMAmerica/New_York2. The Essentials of Health and Safety at the Boundaries of BiosafetyIn actual practice, there is virtually no work setting where occupational risks are limited solely to biological agents. Fire safety, occupational safety, and chemical safety risks are ubiquitous in laboratory and production settings, and sources of radiation can be regularly encountered. Issues regarding insurance coverage and policy limitations can also arise. Given this diversity of possible risks, it is prudent for biosafety professionals to familiarize themselves with the essential aspects of these other specialty areas of loss control. This course is designed specifically to provide a baseline orientation to a series of parallel health and safety professions with which a biosafety professional commonly interacts. Each section begins with a discussion of the relative public health impact of a specialty area and ends with a description of the simple things a biosafety professional can do to assist in keeping the overall organization safe and compliant.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

2. The Essentials of Health and Safety at the Boundaries of Biosafety
Robert Emery, DrPH, RBP, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Bruce Brown, DrPH, CBSP, University of Texas Southwestern Medical Center, Dallas, TX; Rachel Gamble, DrPH, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Scott Patlovich, DrPH, CBSP, University of Texas Health Science Center—Houston, Houston, TX
In actual practice, there is virtually no work setting where occupational risks are limited solely to biological agents. Fire safety, occupational safety, and chemical safety risks are ubiquitous in laboratory and production settings, and sources of radiation can be regularly encountered. Issues regarding insurance coverage and policy limitations can also arise. Given this diversity of possible risks, it is prudent for biosafety professionals to familiarize themselves with the essential aspects of these other specialty areas of loss control. This course is designed specifically to provide a baseline orientation to a series of parallel health and safety professions with which a biosafety professional commonly interacts. Each section begins with a discussion of the relative public health impact of a specialty area and ends with a description of the simple things a biosafety professional can do to assist in keeping the overall organization safe and compliant.

Objectives:

  • Describe the 5 recognized steps of risk management process and why this is important for the biosafety profession
  • Identify the basic elements of a fire and life system program, a chemical safety program, radiation safety program, and a comprehensive hazardous waste management program that can be easily accessed by a biosafety professional
  • Summarize the risk represented by insider threats

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate
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[event time=”8am-5pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 05:00 PMAmerica/New_York3. Basic Risk AssessmentRapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the appropriate practices and containment necessary to avoid exposure to the wide array of hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary in order 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. The conclusions of the groups will be presented.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

3. Basic Risk Assessment
Patrick Condreay, PhD, Biosafety Consultant Services, Carrboro, NC; Anne-Sophie Brocard, PhD, RBP, CBSP, University of Texas Medical Branch—Galveston, Galveston, TX; Betsy weirich, MS, CBSP, SM(NRCM)[icon icon=”0273.png”][/icon], Centers for Disease Control and Prevention, Atlanta, GA
Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the appropriate practices and containment necessary to avoid exposure to the wide array of hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary in order 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. The conclusions of the groups will be presented.

Objectives:

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

Suggested Background: Fundamentals of Biosafety
Target Audience: New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
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[event time=”8am-5pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 05:00 PMAmerica/New_York4. Shipping Infectious Substances Certification CourseThis 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. The course utilizes group discussions and interactive exercises focused on the essential areas of infectious substance shipping. Participants will have the opportunity to mark, label, package, and complete documentation for a variety of infectious substances shipments (Category A, Category B, and Exempt Patient Specimens). Participants will 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. A final written certification exam will be administered. Participants must score at least 80% in order to be certified.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

4. Shipping Infectious Substances Certification Course
Eric Cook, MPH, CBSP, Sandia National Laboratories, Albuquerque, NM
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. The course utilizes group discussions and interactive exercises focused on the essential areas of infectious substance shipping. Participants will have the opportunity to mark, label, package, and complete documentation for a variety of infectious substances shipments (Category A, Category B, and Exempt Patient Specimens). Participants will 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. A final written certification exam will be administered. Participants must score at least 80% in order to be certified.

Objectives:

  • Summarize the various regulations that impact the shipment of infectious substances
  • Using principles of risk assessment, classify biological materials for shipping purposes as either Category A, Category B, Exempt or not regulated
  • Demonstrate how to package, mark, label, and document shipments of infectious substances, Category A, Category B, and dry ice
  • Complete a written exam to qualify for infectious substance shipping certification

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic
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[event time=”8am-5pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 05:00 PMAmerica/New_York5. BSL-3 Design Commissioning BasicsThis course will offer participants a comprehensive design understanding of BSL-3 facilities. This compact design-based course will cover all aspects from planning to commission and will provide the participants an understanding how a biocontainment facility is logically designed and built. The basic steps involved in planning, design, construction, acceptance, and operation that each facility should go through to be effective in primary and secondary containment will be reviewed. Participants will be able to participate in the BSL-3 design processes and understand the influences that vary for BSL-3 facilities through interactive discussions.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

5. BSL-3 Design Commissioning Basics
Paul Langevin, PEng, Merrick & Company, Ottawa, Ontario, Canada; Gilles Tremblay, Merrick & Company, Ottawa, Ontario, Canada; Art Wyatt, PEng, Merrick & Company, Atlanta, GA
This course will offer participants a comprehensive design understanding of BSL-3 facilities. This compact design-based course will cover all aspects from planning to commission and will provide the participants an understanding how a biocontainment facility is logically designed and built. The basic steps involved in planning, design, construction, acceptance, and operation that each facility should go through to be effective in primary and secondary containment will be reviewed. Participants will be able to participate in the BSL-3 design processes and understand the influences that vary for BSL-3 facilities through interactive discussions.

Objectives:

  • Recognize how to participate with BSL-3 design projects
  • Restate the influences of BSL-3 facility design
  • State the operational influences for design criteria
  • Explain BSL-3 project variations and delivery options

Course Requirement: Participants must bring a laptop or tablet with a USB port
Suggested Background: Fundamentals of Biosafety, Risk Assessment, BSL-3—Design and Operations, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Facility Managers, Inspectors, Designers, BSL-3 Facility Building Operators
Audience Level: Intermediate
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[event time=”8am- 12:00 pm”]

Add to Calendar10/09/2015 08:00 AM10/09/2015 12:00 PMAmerica/New_York6. Fundamentals of Microbiology and Infectious DiseaseThis course is intended for those professionals that participate in protocol review, facilities planning, and any other risk assessment activities, but are unsure as to the actual nature of the disease risks of microbiological agents. Biological safety and risk assessment will not be covered in this course. The proposed topics will cover infectious agents, virulence factors, pathogenicities, host-microbe interactions, susceptibility, modes of transmission, and the changes seen in the microbial world. If you don’t know the difference between a TCID50, PFU, or ID50; or why HBV is stable in dried blood and HIV is not; or why influenza is an inhalation hazard; or why public health officials advocate flu shots each year—then this course is for you.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

6. Fundamentals of Microbiology and Infectious Disease
James Klenner, MSc, MPH, MPA, RBP, CBSP, Indiana University—Purdue University Indianapolis, Indianapolis, IN
This course is intended for those professionals that participate in protocol review, facilities planning, and any other risk assessment activities, but are unsure as to the actual nature of the disease risks of microbiological agents. Biological safety and risk assessment will not be covered in this course. The proposed topics will cover infectious agents, virulence factors, pathogenicities, host-microbe interactions, susceptibility, modes of transmission, and the changes seen in the microbial world. If you don’t know the difference between a TCID50, PFU, or ID50; or why HBV is stable in dried blood and HIV is not; or why influenza is an inhalation hazard; or why public health officials advocate flu shots each year—then this course is for you.

Objectives:

  • Define different microorganisms and their pathogenicity
  • Restate the various modes of transmission of microbial pathogens
  • Correlate the host response to microbial infections
  • Develop a basis for various environmental survival trends

Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
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[event time=”1pm-5pm”]

Add to Calendar10/09/2015 01:00 PM10/09/2015 05:00 PMAmerica/New_York7. Biosafety Considerations with Human Gene TransferSince the late 1990s, human gene transfer research has teased the community with the promise of medical breakthroughs using targeted clinical applications with biological materials. Despite setbacks along the way, the field of human gene therapy has made significant advances. This course will provide an overview of human gene transfer research, risk assessment considerations for biosafety professionals and Institutional Biosafety Committees, and outline the regulatory environment for human gene transfer research. Case studies and group discussion will be used to amplify the take home messages.Rhode Island Convention CenterAmerican Biological Safety Association (ABSA)[email protected]falseMM/DD/YYYY

7. Biosafety Considerations with Human Gene Transfer
Christopher Jenkins, PhD, RBP, WIRB-Copernicus Group, Princeton, NJ; David Emery, PhD, WIRB-Copernicus Group, Puyallup, WA
Since the late 1990s, human gene transfer research has teased the community with the promise of medical breakthroughs using targeted clinical applications with biological materials. Despite setbacks along the way, the field of human gene therapy has made significant advances. This course will provide an overview of human gene transfer research, risk assessment considerations for biosafety professionals and Institutional Biosafety Committees, and outline the regulatory environment for human gene transfer research. Case studies and group discussion will be used to amplify the take home messages.

Objectives:

  • Recall the challenges past and present with human gene transfer research into human subjects
  • Generate risk assessments with biological materials used in clinical environments
  • Review the regulatory environment from the FDA and NIH perspectives for human gene transfer research

Suggested Background: Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Biosafety Professionals, Clinical Professionals
Audience Level: Intermediate
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Saturday Preconference Courses[icon url=”/151010precon/” icon=”0231.png”][/icon]