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Manufacturing of Potent Drugs: An Industry Perspective on Facility Design, Measurements and Controls, as Presented to the FDA
Recorded Date: May 2006
Course Type: Recorded On-line Seminar
Speakers
Lesley Burgess, Bsc, Msc, Dip OH, Industrial Hygiene Consultants
Nigel Hamilton, Sanofi-Aventis
Bruce D. Naumann, Ph.D., DABT, Merck & Co.
Edward V. Sargent, MPH, Ph.D., DABT, Merck & Co.
Andy Walsh, Hoffmann-LaRoche
Paul Wreglesworth, AstraZeneca
Julian Wilkins, PharmaConsult US, Inc.
Stephanie Wilkins, PharmaConsult US, Inc.
Description
This Recorded On-line Seminar will bring delegates up to date on the current regulatory thinking with regards to multi-product facilities and "potent" compounds. Delegates will also learn what steps are being taken to move the industry to a science and risk-based approach to determining when dedicated facilites are needed.
This presentation was given to the FDA on January 25, 2006 to address using a risk management approach based on the ICH Q9 document to assist in the decisions for employing risk control strategies, specifically when dealing with High Hazard Compounds. This presentation was developed to show the FDA that multi-product facilites can be safely employed even when producing highly hazardous compounds (aka potent compounds).
Topics Covered
- Risk Management/Risk Assessment
- Exposure Assessment
- Controlling Risk
- Cleaning
Learning Objectives
At the end of this Recorded On-line Seminar, participants will be able to:
- Define Hazard, Exposure and Risk and how they are related
- Understand how an ADI (Acceptable Daily Limit) can be used to develop limits that can be used to evaluate how to control risk
- Compare the differences between Industrial Hygiene (IH) needs and cGMP needs
- View a logic diagram that provides a tool for making risk-based decisions
- Define how to set cleaning limits for cleaning validation to support the control methods employed
Who Should Attend
- Professionals with containment, cross-containment, and product segregation concerns, including personnel who handle materials with an occupational exposure limit below 50 micrograms for APIs, oral solid dosage, inhalation, and parenteral applications.
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What is a Recorded Webinar?
Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.
What are CPIPSM Recorded Webinars?
CPIPSM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) examination..
The Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.
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