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.
Learning Objectives:
Upon completing this course, participants should be able to:
- Understand the CMO business model
- Understand the regulatory requirements for CMO quality oversight
- Understand how to structure your organization for effective CMO oversight
- Understand key points for selecting and qualifying CMOs
- Know how to prepare for and conduct CMO Audits
- Know how to develop a Quality Agreement and how to execute it
- Understand key points for reviewing CMO records
- Know how to resolve issues identified in CMO records
- Know how to manage CMOs on an ongoing basis
Agenda:
DAY 01(8:00 AM to 2:00 PM PT)
- The CMO Business Model
- What is CMO Oversight?
- Regulatory Requirements for CMO Oversight
- FDA Expectations and Warning Letters
- Structuring Your Organization for CMO Oversight
- Manufacturing
- Chemistry / Laboratory
- Quality Assurance
- Regulatory Affairs
- 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
- Key Selection / Qualification Criteria
- 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 02(8:00 AM to 12:30 PM PT)
- Getting to Know Your CMO
- Understanding CMO Operations
- Operational/Communication Style
- How to Deal with the Seven CMO Personality Types
- Review of Key CMO Records
- Batch Records
- Change Controls
- Group Exercise # 5- Change Control Critique
- Deviation Investigations / CAPA
- Group Exercise # 6- Deviation Investigation Critique
- OOS Investigations
- Group Exercise # 7- OOS Investigation Critique
- Hot Topic- Data Integrity
- Routine CMO Audits
- Audit Planning
- Audit Execution
- Differences from CMO Qualification Audits
- Ongoing CMO Oversight
- Overall Considerations
- Elements of Effective Ongoing CMO Oversight
Instructor Profile:
Michael Ferrante
President, Quality and Compliance Associates LLC
President, Quality and Compliance Associates LLC
Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.
During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, prepared and controlled compliance plans at both a site and corporate level.