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The Center for Professional Advancement, Amsterdam, The Netherlands
16-18 June 2008
Who Should Attend
This practical program will be of benefit to all medical device personnel involved with their company’s Complaint Systems including:- Implementation
- Management
- Regulatory Compliance
- Training
- Product Performance Monitoring
- Auditing
Description
Complaint handling systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry FDA environment and will give you tools for survival. It will provide a step-by-step guide to the setting-up, operation, management and auditing of a complaint system for today’s medical device industry environment.
There will be case studies in which various examples of complaint systems will be presented. Pragmatic, simple, statistical trend methods will be reviewed and attendees will utilize what they learn in a series of workshops.
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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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Jim Colyn; President, Jim Colyn & Associates Quality Consulting
Jim Colyn is a Registered Lead Assessor of Quality Systems (RAB) with fourteen years experience in Quality Systems Management. Mr. Colyn is currently the President and principle consultant for Jim Colyn and Associates Quality Consulting, specializing in compliance for the tissue industry. Prior he was the head of Quality and Compliance for a large tissue processor, with responsibilities for ensuring overall compliance to Federal and State Regulations, and American Association of Tissue Bank (AATB) Standards for Tissue Banking. In that role, he and his staff of 30 quality professionals compiled an enviable regulatory compliance history.
Mr. Colyn serves as Chairman of the AATB Education Committee, and is a member of the AATB Quality Taskforce, responsible for the Annual AATB Quality Workshop. He has led in the successful ISO 9000 registration of five establishments in the oil service tools, plastics and elastomer industries, and ISO 13485 Registration of two Human Tissue/Medical Device Organizations.
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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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info@cfpa.com
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