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CfPA - The Center for Professional Advancement, New Brunswick, NJ
March 14-15, 2011
Who Should Attend
This course is intended for all personnel involved with the following areas of pharmaceutical and medical device sterile facilities:
• Design
• Construction
• Validation
• Operation
• Monitoring
Other personnel who will find this course of interest:
• Design Engineers
• Contractors
• Equipment Manufacturers
• QA/QC
• Regulatory Affairs
• Production
• Maintenance
Description
This 2-day course reviews the current state of the technology associated with pharmaceutical, medical device, active pharmaceutical ingredient, medical component, R&D, and microbiological clean rooms. Regulations and guidelines for the U.S. and E.U. will be covered.
The course is conducted in an environment that encourages discussion, questions, input and debate by the attendees. Case studies of actual rooms are presented. Attendees are invited to bring their own projects for discussion and review.
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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, William G. Marshall and Associates
William G. Marshall, is President of William G. Marshall and Associates. He has over thirty 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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