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The globalization of the pharmaceutical supply chain has led increased us 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. Since FDA is holding firms using CMOs responsible, it is imperative that your organization have a robust CMO management system. At the end of the day, your organization’s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company’s compliance profile.

This seminar will help all personnel responsible for CMO oversight understand how to manage CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, Quality Agreements, Understanding of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be discussed. This is a practical how-to course, designed to provide participants with skills they can immediately apply to CMO oversight within their own organizations. Group exercises will allow participants to practice skill sets with feedback from the instructor.

Learning Objectives:

Upon completing this course, participants should be able to:

  • 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 how to prepare for and conduct CMO Qualification Audits
  • Learn how to develop a Quality Agreement and how to execute it
  • Learn how to understand CMO operations
  • Learn key points for reviewing CMO records
  • Learn how to resolve issues identified in CMO records

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


Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

If the Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) is important to your business, act now and make the appropriate connections. See the contact information below.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 11/17/2016 - 11/18/2016
Conference/Event Hours: 8:00 AM to 1:00 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Manufacturing, Medical, Sciences
Estimated Attendance: 30
Cost to Attend: One Registration - $1799
Audience: Pharmaceutical Development
Quality Control
Regulatory Affairs
Quality Assurance
Project Management
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
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  Water: n/a
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  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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