FDA Discusses Regulatory Aspects of the Biopharmaceutical Baseline Guide

Recorded Date: August 2004
Course Type: Recorded On-line Seminar

Speakers:
Kip Priesmeyer, Investigator, FDA
Jeff Biskup, Principal, CRB Consulting

This Recorded On-line Seminar addresses many of the regulatory aspects presented in ISPE's newly released Baseline® guide, including open vs. closed processing; classified vs. controlled-non-classified space; process segregation; single vs. multi-product facilities; water quality and product protection strategies. These topics are supplemented with discussion of actual 483 observations that have been cited during inspections.

After completing this Recorded On-line Seminar, participants will have a greater understanding of FDA's current thinking on those regulatory uncertainties that face the biopharmaceutical industry.

Who Should Attend
This Recorded On-line Seminar benefits professionals who design facilities or systems for pharmaceutical and biotech functions or manage regulated facilities, regulators who use the Guides in conjunction with inspections, and anyone who would like to understand how to use the Baseline® Guides more effectively.

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CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) 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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