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PAI: Surviving the Pre-Approval Inspection

 
  September 11, 2017  
     
 
CfPA-The Center for Professional Advancement, Online Live
October 23, 2017 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators working within the Pharmaceutical, and related industries. It will also be valuable to documentation specialists, auditors and those in regulatory affairs. Personnel from the following departments will find the course beneficial:

  • Research and Development
  • Quality Assurance and Control
  • Manufacturing/Operations
  • Facilities
  • Finance 
  • IT
  • Audit
  • Training
  • Technical Support

This training will also benefit suppliers of equipment and services to the Pharmaceutical, Medical Device and related industries. 

Course Description
The Pre-Approval Inspection (PAI) is the last major regulatory hurdle prior to a product launch. It is essential that the manufacturing site satisfy FDA expectations during and in follow up to the PAI. This 90-minute accredited training draws on experiences from over a dozen PAI’s and discusses pragmatic, simple strategies for PAI preparations, conduct and follow up.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   William G. Marshall, President, William G. Marshall & Associates

William G. Marshall is President of William G. Marshall and Associates. He has over forty years of 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.

Mr. Marshall’s training continues to receive CfPA’s most highly rated reviews. He liberally uses Case Studies from Warning Letters and Consent Decrees and his 40 plus years working in manufacturing and consulting in over 25 countries. Attendees are encouraged to question, debate, and share their own problems and successes. Mr. Marshall’s style of training is to keep the course very interactive. Attendees find his enthusiasm, knowledge, and experience, wrapped in a sense of humor, stimulating as well as informative.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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