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Pharmaceutical cGMP-Quality Systems

 
  March 06, 2017  
     
 
CfPA-The Center for Professional Advancement, Online Live
March 21, 2017 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
Professionals in the pharmaceutical industry that engage in the manufacture, processing, packaging or holding of drug products as well as regulatory personnel will find this course beneficial. CFR 21, Parts 211.25(a) and (b) require cGMP training on “a continuing basis for all personnel involved the manufacture of pharmaceuticals.”

This course is for employees that have been introduced to the basic cGMP concepts and need a deeper exposure to cGMP Quality Systems. 

Course Description
This 90-minute accredited online training course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality System, the primary system of FDA’s Systems Based Inspection Program. Special attention will be paid to components of the system that are often problematic and focused on by regulators. Identification of common tools that can be used by pharmaceutical personnel to solve problems and the elimination of manufacturing non-compliance will be discussed.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
William 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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