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 |
Edit Freely
Category
Deadline: March 12, 2019 | Date: March 12, 2019
Venue/Country: U.S.A
Updated: 2019-01-26 18:11:31 (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 The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.