CfPA-The Center for Professional Advancement, 60 Minute Accredited Online Training
November 6, 2014 at 11:00 a.m.–12:00 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, Medical Device and Biologics Industries and will be especially valuable to anyone involved in or intending to become involved in Combination Products. 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 above industries. Description
This course will be available On Demand: November 7, 2014
The FDA has recently published New Regulations addressing Combination Products. (21 CFR, Part 4) and established an office of combination products. This 60-minute accreditedonline training course will present a strategy for compliance with these new regulations and to assure that the necessary systems and metrics are in place.
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Invited Speakers:
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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.
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