Containment: A Risk-Based Approach (E06)

23-24 February
CEUs: 1.2

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Course Level is Fundamental to Intermediate

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(2 CM Points Applied for Industrial Hygienists)

Planned and Implemented by the ISPE Containment Community of Practice (COP)

Examine the latest scientific, risk-based approaches to the containment of potent compounds. Is it an idealistic concept? Maybe; maybe not. Join a discussion evaluating containment systems and approaches specifically for potent and highly hazardous compounds. What happens when the design/approach does not work? How do you overcome risk of failure? The FDA will be invited to speak on how science and risk-based approaches to containment are viewed. You will also hear directly from companies and subject matter experts who have successfully implemented scientific, risk-based approaches, speakers who are innovators on assessing Contract Manufacturing Organizations (CMOs), those who have successfully communicated containment strategies and from CMOs who have implemented them. Learn how to use Industrial Hygiene (IH) data to support assessments.

With an increasing focus on containment for pharmaceutical manufacturing, active pharmaceutical ingredients (APIs) are becoming more targeted, hence more potent and more prolific. Environmental, health and safety (EHS) pressures push for the use of engineering controls, but the implementation of RABS and isolation technology may be an ideal solution for some pharmaceutical manufacturers, but may not be the most efficient processing option, nor most cost effective solution for others. A risk-based approach to containment offers some alternatives.

Leaders

Speakers

    How You Will Benefit

    At the conclusion of this session, participants will be able to:

    • Recognize that different types of toxicology limits are set for worker, product, and environmental protection
    • Recognize or describe the following containment concepts: Contain at the source; Containment challenge; Material migration; and Risk
    • Identify containment technologies and their position in the containment hierarchy
    • Recognize applications of hierarchy of containment solutions to real-world containment challenges
    • Describe how other industry professionals solved containment challenges
    • Understand new technologies available and how they impact containment and cross-contamination

    Who Should Attend

    Engineers, EH&S, Project Managers, Product Managers, Production Managers and Specialists, Technical Operations, Maintenance, Purchasers of containment equipment, Quality Managers and Specialists, Toxicologists

    This Session relates to the following Communities of Practice (COPs)

    Containment

    www.ISPE.org/COPs

    Related Guidance Documents, Articles, and Publications

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