In September, the FDA published its long-awaited Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. As its title suggests, the 60-page Guidance emphasizes cGMP in this critical area of pharmaceutical manufacturing.

 In this Recorded On-line Seminar, you'll obtain timely information and gain an understanding of the key requirements and expectations expressed in the Guidance, to help you begin applying the GMPs in your own manufacturing operation. You'll hear first-hand from Rick Friedman, the leader of this vital project within the FDA, who presented the highlights of the Guidance and answered audience questions. Topics to be covered include a summary review of the aseptic cGMP development process; an introduction to the document and a summary of scope, drivers and principles and key features of the Guidance.

At the end of this Recorded On-line Seminar, participants will be able to understand the drivers behind this important document and the key principles, and how they can be deployed not only in new aseptic manufacturing facilities, but within the context of established operations and GMP inspections.

Who Should Attend
This Recorded On-line Seminar is essential for all engineering, scientific and operations personnel responsible for specification, installation, start-up, qualification, audit, assessment and operation of sterile products manufacturing assets.

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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