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The Center for Professional Advancement, Isla Verde, Puerto Rico
March 10-12, 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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Michael Barile; Managing Partner, Barile & Associates Consulting for the Medical Device, Pharmaceutical, Human Tissue, and Biotechnology Industries
Michael Patrick Barile has over twenty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multinational corporations, specializing in turnaround situations.
Mr. Barile is Managing Partner of Barile & Associates, a consulting firm serving the medical device, human tissue, pharmaceutical and biotechnology industries. Barile & Associates provides a range of services including software, process and equipment validation as well as quality system consulting, training, staffing, organizational development, auditing and 483/Warning Letter resolution.
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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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