This Recorded On-line Seminar will help your firm improve its inspection readiness by better understanding the focus of FDA inspections of biopharmaceutical processes. This presentation is identical to that presented to investigators who attend FDA's Active Pharmaceutical Ingredients training given by Kip Priesmeyer of Team Biologics. The On-line Seminar will focus on an investigator's approach to inspecting quality systems, as well as processes and unit operations that are related to biopharmaceutical manufacturing. The presentation will include identification of key process variables and controls that are inherent in fermentation, purification, segregation and validation. The discussion is supplemented by examples of actual observations that have been cited on 483's.

 Learning Objectives
At the end of this Recorded On-line Seminar, participants will be able to:

• Describe the FDA's approach to inspecting bulk biopharmaceutical production facilities

Who Should Attend

• Professionals responsible for QA, compliance, manufacturing, and validation of biopharmaceutical operations

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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 CPIP^SM Recorded Webinars?

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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