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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Event Details

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Time: February 16, 2021 at 7am to February 17, 2021 at 1pm
Location: online
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: Dec 16, 2020

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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 oversight of CMOs is the key to assuring product safety and safeguarding your firm’s compliance profile.

Learning Objectives:

Upon completing this course, participants should be able to:

  • Understand the CMO business model
  • Understand the regulatory requirements for CMO quality oversight
  • Understand how to structure your organization for effective CMO oversight
  • Understand key points for selecting and qualifying CMOs
  • Know how to prepare for and conduct CMO Audits
  • Know how to develop a Quality Agreement and how to execute it

Who will Benefit:

This course is designed for people tasked with oversight of these CMO functions:

  • Manufacturing operations
  • Quality Control operations
  • Quality Assurance operations

The following personnel will benefit from the course:

  • Pharmaceutical Development
  • Quality Control
  • Validation
  • Regulatory Affairs
  • Quality Assurance
  • Project Management

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