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. 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

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

DAY ONE

• The CMO Business Model

• What is CMO Oversight?

• Regulatory Requirements for CMO Oversight

• FDA Expectations and Warning Letters


Structuring Your Organization for CMO Oversight


1. Manufacturing

2. Chemistry / Laboratory

3. Quality Assurance

4. Regulatory Affairs

5. Project Management


Group Exercise # 1- Structuring Your Organization


CMO Selection and Qualification


Key Selection / Qualification Criteria


• Overall Considerations

• Considerations for API CMOs

• Considerations for Drug Product CMOs

• Considerations for Aseptic Manufacturing CMOs

• Considerations for Testing Laboratory CMOs

• Evaluating CMOs vs. Selection / Qualification Criteria


Group Exercise # 2- CMO Selection and Qualification


• Evaluating CMOs vs. Selection / Qualification Criteria

• Group Exercise- Selection and Qualification

1. Evaluating CMOs vs. Selection / Qualification Criteria


Group Exercise # 2- CMO Selection and Qualification


1. Evaluating CMOs vs. Selection / Qualification Criteria

2. Group Exercise- Selection and Qualification

CMO Qualification Audits


Overall Considerations for CMO Qualification Audits


CMO Questionnaires


• Risk Assessments for Use of Questionnaires

• Evaluation of Questionnaire Responses


Audit Planning


• Auditor Selection

• Determining Audit Purpose / Scope

• Audit Agenda


Audit Execution


• Introductory Meeting / Orientation

• Area Tours

• Document Review / Interviews

• Time Management

• Audit Findings


Group Exercise # 3- Audit Agenda


The Quality Agreement


• Regulatory Requirements

• Elements of the Quality Agreement

• Negotiating the Quality Agreement

• Executing the Quality Agreement


Group Exercise # 4- Quality Agreement

DAY TWO

Getting to Know Your CMO


 Understanding CMO Operations
 Operational/Communication Style


Case Study # 5- CMO Personality Types


Review of Key CMO Records

• Batch Records

• Change Controls

• Deviation Investigations / CAPA

• OOS Investigations

Hot Topic- Data Integrity

Ongoing CMO Oversight

• Overall Considerations

• Elements of Effective Ongoing CMO Oversight