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The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
March 9, 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, 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
The FDA has recently published Proposed New Regulations addressing Combination Products. (21 CFR, Part 4) and established an office of combination products. This 90-minuteaccredited online training course will present a strategy for compliance with these new regulations and to assure that the necessary systems and metrics are in place.
Module 1:
• What is a Combination Product?
• Examples of Combination Products
• Why are these new regulations necessary?
• What are the most recent FDA proposed regulations?
Module 2:
• How can I assure that my systems and work aren't
repetitious, while at the same time not having some
requirement of the regulations overlooked?
• Who should have responsibility for monitoring these
systems?
• Which parts of the regulations are likely to be the most
challenging, and how should I address these parts?
Module 3:
• Post marketing safety reporting for Combination Products:
Harmonizing the requirements for Drugs, Devices, Biologics
and Tissue Products
• Metrics for monitoring and auditing these systems
• Strategies for tracking how Office of Regulatory Affairs
(ORA) will inspect Combination Product manufacturing
sites
Question and Answer Session
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Organized by:
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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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