Implementing a Biosafety Program Primer
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
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Optional CPE Credit: 1.0
Overview:
Implementing a Biosafety Program Primer discusses the principles, practices, and personnel related to biosafety and biosecurity programs. This class explains the identification principles of biologic and select agents, categorizing them into four risk levels. It breaks down the practices involving various techniques, such as targeted diversification, chain shuffling, and formulation, which aim to address CMC liabilities. This primer discusses the roles of personnel involved in biosafety programs, including the institutional biosafety committee, biosafety officer, and biosecurity director. It ends with a detailed look at workplace controls and how to report/ investigate breaches should they occur.
- Section 1: Principles: Explore the fundamentals of biosafety and biosecurity programs, including the classification of biological and select agents into four risk levels, and learn how to manage infectious agents in various laboratory settings.
- Section 2: Personnel: Discover the world of structure-based affinity maturation and methods like targeted diversification and chain shuffling. Explore the intricacies of formulation, including considerations such as CMC liabilities, aggregation, solubility, immunogenicity, and glycation.
- Section 3: Practices: Explore the roles and responsibilities within a biosafety program, including the Institutional Biosafety Committee (IBC) and key positions like biosafety officers, chief scientific officers, principal investigators, and more.
- Section 4: Controls: Learn comprehensive risk assessment strategies, covering areas such as change management, work practice controls, PPE, decontamination, facility and equipment maintenance, biosecurity measures, incident reporting, emergency plans, inventory control, and more to ensure a safe laboratory environment.
By the end of the course, participants will be able to:
- Become fluent in the fundamental principles required to establish a biosafety and biosecurity program.
- Identify the potential risks involved in operating a facility that deals with biological agents.
- State the guidelines, inventory systems, training, and communication protocols needed to manage biosafety and biosecurity risks effectively.
- Describe the workplace controls commonly implemented to control and mitigate risks in a biosafety and biosecurity program.
- Investigate the various roles and organizational structures within a biosafety and biosecurity program.
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