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Feb
16

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

 
 Seminar/trade show (noCPF)

When:

  16 Feb 2021 through 17 Feb 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/pharmaceutical-contract-manufacturing-organizations-cmos-seminar-training-80389SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Pharmaceutical / Medicinal

Keywords:


Event description:

The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also presents unique compliance risks, particularly since operations are not under your direct control. Compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious cGMP compliance and data integrity issues at foreign CMO sites. If you use CMOs, your firm is fully responsible for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that firms using CMOs will be held accountable for CMO compliance to cGMPs, as well as for CMO adherence to Sponsor regulatory commitments. Issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your firm. Therefore, it is imperative that your organization have a robust CMO management system. At the end of the day, your ability to provide proper quality ... Read more

Posting date:

14 December 2020  |  261 views

Placement:

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