DUBLIN–(BUSINESS WIRE)–The "Effective
Quality Oversight of Pharmaceutical Contract Manufacturing Organizations
(CMOs): One and a Half day In-Person Seminar" conference has
been added to Research and Markets' offering.

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:

• 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
• Learn how to prepare for and conduct routine CMO audits
• Learn how to manage CMOs on an ongoing basis

Who Should Attend:

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

For more information about this conference visit https://www.researchandmarkets.com/research/zz83n4/effective_quality

Contacts

Research and Markets
Laura Wood, Senior Manager
[email protected]
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceutical
Manufacturing