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Who should attend Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Manufacturing operations, Quality Control operations, Quality Assurance operations
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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 fully 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

Course Outline:
DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

The CMO Business Model
Regulatory Requirements & FDA Expectations for CMO Oversight
Structuring Your Organization for CMO Oversight
Manufacturing
Chemistry / Laboratory
Quality Assurance
Regulatory Affairs
Project Management
CMO Selection and Qualification
Key Selection / Qualification Criteria
API Manufacturers
Drug Product Manufacturers
Testing Laboratories
Aseptic Manufacturers
Evaluating CMOs vs. Selection / Qualification Criteria
Group Exercise- Selection and Qualification
CMO Qualification Audits
CMO Questionnaires
Risk Assessment for Use of Questionnaires
Good vs. Bad Questionnaires
Evaluation of Questionnaire Responses
Audit Planning
CMO Background/Research
Auditor Selection
Audit Agenda
Audit Execution
Introductory Meeting / Orientation
Area Tours
Document Review / Interviews
Time Management
Group Exercise- Qualification Audits
The Quality Agreement
Regulatory Guidance Documents
Elements of the Quality Agreement
General Elements
Manufacturing / Testing Elements
Quality Assurance Elements
Negotiating the Quality Agreement
Executing the Quality Agreement
Group Exercise- Quality Agreement

DAY TWO (9:00 AM – 1:00 PM)

Getting to Know Your CMO
Understanding CMO Operations
Operational/Communication Style
The Seven CMO Personality Types
Review of Key CMO Records
Batch Records
Change Controls
Group Exercise- Change Control Critique
Deviation Investigations / CAPA
Group Exercise- Deviation Investigation Critique
OOS Investigations
Group Exercise- OOS Investigation Critique
Routine CMO Audits
Audit Planning
Audit Execution
Group Discussion- Routine CMO Audits
Ongoing CMO Oversight
Depth and Breadth of Oversight
Managing Routine / Critical Issues
Building Relationships
Project Management

Seminar Summary:

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. (see full course description)

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