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2nd Edition  Conference

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations


"Regulatory requirements for CMO quality oversight"
The globalization of the pharmaceutical supply chain has led increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites.If you use CMOs, your company has the ultimate responsibility for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as adherence to regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company.

Highlights

  • Understand the CMO business model,Learn the regulatory requirements for CMO quality oversight
  • Learn how to structure your organization for effective CMO oversight
  • Learn key points for selecting and qualifying CMOs,Learn key points for reviewing CMO records
  • Learn how to prepare for and conduct CMO Qualification Audits,Learn how to understand CMO operations
  • Learn how to prepare for and conduct routine CMO audits,Learn how to manage CMOs on an ongoing basis

Timings

8:00 AM - 4:30 PM (Nov 14) (General)
8:00 AM - 4:30 PM (Nov 15) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

14-15 Nov 2019 Interested
01-02 Aug 2019 1st Edition


Frequency Bi-annual

Official Links

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ComplianceOnline USA

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User Community [ Users who have shown interest for this Event ]

Rajagopal Appavu

Rajagopal Appavu

CEO at ChemSafety MSDS LLC

Tampa, United States

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