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The Center for Professional Advancement, 90 Minute Accredited Online Training
September 29, 2009 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training will benefit professionals involved in the medical device industry in departments such as regulatory affairs, QC, QA, product development, sales, training, operations, engineering, and legal. Description
The Complaint System will be one of the Key Systems reviewed in depth by the FDA Investigator. It is one of the major sources of issues cited in 483's and Warning Letters.
This 90-minute accredited online training will give clear, pragmatic, instructions on how to establish elements of the complaint system; How to recognize a complaint; Where complaints originate; Documentation of a complaint; Trending and when to investigate; What is an MDR; Response letters; Off the shelf complaint systems; As well as how to what, when and how to communicate complaint issues to upper management.
Several case studies from actual industry complaint systems will be used as examples of typical problems.
Module 1:
• Background-Regulatory Requirements
• Key Definitions: what is a complaint, anyway?
• What needs to be in my complaint procedure?
Module 2:
• Complaint Receipt
• Complaint Review: Is it an MDR?
• Complaint Investigations; so, why did it fail anyway?
Module 3:
• Do I need to take Corrective Action?
• Can I close this complaint already?
• What is Complaint Trending and why do I need to do it?
• Resources, Record-keeping, and other Essentials
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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salbers@cfpa.com
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