ComplianceOnline

The globalization of the pharmaceutical supply chain has led increased us 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.

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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 will Benefit:

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
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Day 01(8:00 AM - 4:30 PM)
  • 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 02(9:00 AM - 1:00 PM)
  • 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
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Andrew Campbell

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.

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Seminar One Registration

November 16-17, 2017, San Diego, CA

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November 16-17, 2017, San Diego, CA
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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Location:

San Diego, CA
(Venue to be announced shortly)

November 16-17, 2017

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