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.
This seminar will help all personnel responsible for CMO oversight understand how to ensure effective quality oversight of CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, CMO Audits, Quality Agreements, Oversight 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 addressed. Techniques for assuring robust CMO Oversight programs in light of COVID-19 restrictions will also 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. Case studies will allow participants to practice skill sets in cooperation with the instructor.
Upon completing this course, participants should be able to:
This course is designed for people tasked with oversight of these CMO functions:
The following personnel will benefit from the course:
DAY 01 (11:00 AM EDT TO 3:00 PM EDT)
· THE CMO BUSINESS MODEL
· WHAT IS CMO OVERSIGHT?
· CMO OVERSIGHT AND COVID-19 RESTRICTIONS
· REGULATORY REQUIREMENTS FOR CMO OVERSIGHT
· FDA EXPECTATIONS AND WARNING LETTERS
· STRUCTURING YOUR ORGANIZATION FOR CMO OVERSIGHT
2. CHEMISTRY / LABORATORY
3. QUALITY ASSURANCE
4. REGULATORY AFFAIRS
5. PROJECT MANAGEMENT
6. GROUP EXERCISE # 1- STRUCTURING YOUR ORGANIZATION
· CMO SELECTION AND QUALIFICATION
1. OVERALL CONSIDERATIONS
2. SELECTION CRITERIA / PROCESS
3. QUALIFICATION CRITERIA / PROCESS
4. EVALUATING CMOS VS. SELECTION / QUALIFICATION CRITERIA
5. CASE STUDY # 2- EXAMPLE OF SELECTION SCORING MATRIX
· CMO AUDITS (REMOTE AUDITING PERSPECTIVE)
1. OVERALL CONSIDERATIONS
2. QUALIFICATION VS. ROUTINE AUDITS
3. CMO QUESTIONNAIRES
V PURPOSE OF QUESTIONNAIRES
V QUESTIONNAIRE TOPICS / RESPONSES
1. AUDIT PLANNING
V AUDIT PURPOSE / SCOPE
V AUDIT AGENDA
2. AUDIT EXECUTION
V DOCUMENT REVIEW / INTERVIEWS
V TIME MANAGEMENT
V AUDIT FINDINGS / CAPAS
3. GROUP EXERCISE # 3- AUDIT AGENDA
· THE QUALITY AGREEMENT
4. REGULATORY REQUIREMENTS
5. GENERAL ELEMENTS OF THE QUALITY AGREEMENT
6. NEGOTIATING THE QUALITY AGREEMENT
7. EXECUTING THE QUALITY AGREEMENT
8. CASE STUDY # 4- QUALITY AGREEMENT: KEY PITFALLS
DAY 02 (11:00 AM EDT TO 3:00 PM EDT)
· GETTING TO KNOW YOUR CMO
1. UNDERSTANDING CMO OPERATIONS
2. OPERATIONAL/COMMUNICATION STYLE
3. CASE STUDY # 5- CMO PERSONALITY TYPES
· REVIEW OF KEY CMO RECORDS
1. BATCH RECORDS
2. CHANGE CONTROLS
3. DEVIATION INVESTIGATIONS / CAPA
4. OOS INVESTIGATIONS
· HOT TOPIC- DATA INTEGRITY
· ONGOING CMO OVERSIGHT
1. OVERALL CONSIDERATIONS
2. ELEMENTS OF EFFECTIVE ONGOING CMO OVERSIGHT
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.