FDA Audit


Pharmaceutical Contract Manufacturing Organizations (CMOs) have become increasingly prevalent due to the globalization of the pharmaceutical supply chain. While utilizing CMOs offers numerous advantages, it also introduces distinct compliance risks, especially given that operations are not directly controlled. Notably, FDA Warning Letter trends highlight compliance and data integrity issues at foreign CMO sites, emphasizing the significance of these risks.

When engaging CMOs, your company bears full responsibility for product quality, safety, efficacy, and cGMP compliance. The FDA has clearly stated that firms utilizing CMOs are accountable for ensuring their compliance with cGMPs and regulatory commitments. Any issues identified at the CMO can lead to FDA 483s and Warning Letters directed at your firm. Thus, establishing a robust CMO management system becomes imperative to ensure proper quality oversight, uphold product safety, and maintain compliance.

Why You Should Attend:

This seminar focuses on equipping personnel responsible for CMO oversight with the necessary knowledge to effectively ensure quality oversight throughout the entire CMO engagement process. It covers essential aspects such as Selection and Qualification, CMO Audits, Quality Agreements, Oversight of CMO Operations, and Review of Key CMO Records. The seminar also addresses considerations for different manufacturing types and offers techniques for managing challenging CMO situations. Additionally, it explores strategies for maintaining robust CMO Oversight programs amidst COVID-19 restrictions.

Delivered in a practical how-to format, this course empowers participants with actionable skills applicable to CMO oversight in their respective organizations. Engaging case studies provide opportunities to practice these skill sets under the guidance of the instructor.


DAY 1 (10.30 AM to 3 PM) 
DAY 2 (10.30 AM to 3 PM) 
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
  • Manufacturing
  • Chemistry / Laboratory
  • Quality Assurance
  • Regulatory Affairs
  • Project Management
  • Group Exercise # 1- Structuring Your Organization

CMO Selection and Qualification
  • Overall Considerations
  • Selection Criteria / Process
  • Qualification Criteria / Process
  • Evaluating CMOs vs. Selection / Qualification Criteria
  • Case Study # 2- Example of Selection Scoring Matrix

CMO Audits (Remote Auditing Perspective)
  • Overall Considerations
  • Qualification vs. Routine Audits
  • CMO Questionnaires
    • Purpose of Questionnaires
    • Questionnaire Topics / Responses
  • Audit Planning
    • Audit Purpose / Scope
    • Audit Agenda
  • Audit Execution
    • Document Review / Interviews
    • Time Management
    • Audit Findings / CAPAs
  • Group Exercise # 3- Audit Agenda

The Quality Agreement
  • Regulatory Requirements
  • General Elements of the Quality Agreement
  • Negotiating the Quality Agreement
  • Executing the Quality Agreement
  • Case Study # 4- Quality Agreement: Key Pitfalls

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 Latest Updates
  • Applying consistent policies to all records
  • Data Integrity Controls
  • Flags for Parallel Record-Keeping
  • Life Cycle Assessments
  • Evaluation of Current Enforcement Trends

Ongoing CMO Oversight
  • Overall Considerations
  • Elements of Effective Ongoing CMO Oversight

Seminar Objectives:

  • 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

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Pharmaceutical Development Professionals
  • Validation Professionals
  • Project Managers
  • Everyone tasked with oversight of CMO functions
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