Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) (Tampa, FL - August 2-3, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs): One and a Half day In-Person Seminar" 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.

Agenda

Day 1 (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 2 (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

For more information about this conference visit https://www.researchandmarkets.com/research/5tppwd/effective_quality?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceutical Manufacturing

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceutical Manufacturing