Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations: 2 Day Virtual Training Seminar

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Nov 14, 2023, 20:45 ET

DUBLIN, Nov. 14, 2023 /PRNewswire/ -- The "Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations" training has been added to ResearchAndMarkets.com's offering.

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.

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.

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

Key Topics Covered:

DAY 1

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

DAY 2

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

For more information about this training visit https://www.researchandmarkets.com/r/ynzqhw

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SOURCE Research and Markets