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Keys to Risk Management: Implementation, Documentation, Monitoring and Mitigation

  September 22, 2009  
The Center for Professional Advancement, 90 Minute Accredited Online Training
December 10, 2009 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend
This program will benefit anyone wanting to gain an overview of how to approach risk management in the Pharmaceutical, Biologics, Medical Device or Human Tissue industries including personnel in:

  • Q.A.
  • R&D
  • Validation 
  • Manufacturing
  • Technical Support 
  • Audit 
  • Q.C.
  • Documentation Functions

This 90-minute accredited training will focus on the current industry-regulatory environment and will give you tools for survival and success in developing a Risk management system. It will provide a step-by-step guide to the essential requirements of a Risk Management System including the basics of implementation, documentation and monitoring, plus guidance for mitigation once a risk has been identified. Typical problems and risk system failures drawn from actual case studies will also be addressed.

Module 1:
  • What is risk management and why should we do it?
  • Implementing the basic 4 parts of the system,it's subparts, 
    and strategies for implementation
  • A typical Risk management plan and format

Module 2:
  • What is a life cycle approach to the system?
  • Documenting the system
  • Examples of typical risk analyses from pharmaceuticals, 
    biologicals, medical devices, and human tissue

Module 3:
  • Risk Mitigation: What are steps we can take to address 
    risks once we have identified them?
  • What departments play key roles in the risk management 
  • How can we measure the effectiveness of the system?
  • What are typical risk system disasters and how can they 
    be corrected

Question and Answer Session

Organized by: The Center for Professional Advancement
Invited Speakers: William G. Marshall, President of William G. Marshall and Associates; Consultant to the worldwide drug and device industry as well as to the FDA and worldwide lecturer in GMP related issues.

William G. Marshall is President of William G. Marshall and Associates. He has over twenty years experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational pharmaceutical corporations as well as start-up ventures. He has been the Director of a major reference laboratory, and has been active in clean room design and validation. In the last five years, he has acted as a third party in several consent decrees.

Mr. Marshall is currently a consultant to the worldwide drug and device industry as well as to the FDA. He lectures worldwide in GMP related issues including Clean Room Technology and Sterilization. In the past 18 months, he has been involved in 10 Pre-Approval Inspections that include the first aseptic processed injectables from India, the first ever drugs from Turkey, and APIs from China, that were all approved for introduction to the US market. He has a Master's Degree in Biology from Georgetown University, Washington, DC.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: salbers@cfpa.com
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