CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Website https://www.complianceonline.com/cmo-supplier-quality-agreements-how-to-comply-with-new-fda-and-eu-g |
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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 The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.Areas Covered in the Webinar:The who and what of a good Quality AgreementWhat a Quality Agreement is - and is notResponsibilities of the owner vs. contract facilityGMP responsibilitiesA comparison of the new guidelines from the FDA and the EUKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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