Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) Seminar: Tampa, FL, United States – November 14-15, 2019 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)” conference has been added to ResearchAndMarkets.com’s offering.

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.

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.

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 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 Should Attend:

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

Agenda:

Day 1

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

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

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 2

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

For more information about this conference visit https://www.researchandmarkets.com/r/9aj9hf

Contacts

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Laura Wood, Senior Press Manager

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