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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
March 16, 2010 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 medical device industry. 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 since 2006 and discusses pragmatic, simple strategies for PAI preparations, conduct and follow up.
Module 1:
• What is a PAI?
• Preparing for the PAI
• Assigning tasks to various departments and rehearsing
Module 2:
• What systems are likely to be covered and how is this
typically done?
• Risk Analysis...A good tool for predicting what course the
investigation will take
• What Documentation should we have at the "War Room"?
• How to interface with the FDA during the Investigation
Module 3:
• The Wrap-up meeting. Discussing the 483
• How to address observations
• Common mistakes to avoid
Question and Answer Session
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Organized by:
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CfPA - The Center for Professional Advancement |
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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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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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