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CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

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Website https://www.complianceonline.com/cmo-supplier-quality-agreements-how-to-comply-with-new-fda-and-eu-g | Edit Freely

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Deadline: July 17, 2018 | Date: July 17, 2018

Venue/Country: online event, U.S.A

Updated: 2018-06-11 14:29:03 (GMT+9)

Call For Papers - CFP

Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents will be presented with differences highlighted and discussed. The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.

Areas Covered in the Webinar:

The who and what of a good Quality Agreement

What a Quality Agreement is - and is not

Responsibilities of the owner vs. contract facility

GMP responsibilities

A comparison of the new guidelines from the FDA and the EU


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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