Conference Program

Wednesday, September 24, 2008

300 Advanced Good Manufacturing Practices — 21 CFR, Part 820

Instructor: John Gagliardi, President, Midwest Process Innovation This session will provide attendees: Guidance to making decisions based upon quality systems’ logic and regulatory edict Process orientation techniques for compliance and effective systems Using the architecture of 21 CFR, Part 820 to your advantage Industry and peer benchmarking opportunity Understanding and dealing with post-market issues Specific issues discussed will include: Management review Management commitment Quality planning Quality audit results Design change Training and competency DHF — DMR — DHR Supplier control overseas Manufacturing changes Process validation Software validation Inspection, measuring and test equipment Non-conforming product Risk management MDR Corrective and preventive action Complaint handling

A complete conference brochure PDF is available by clicking here

ABOUT THE INSTRUCTOR

John Gagliardi, President, Midwest Process Innovation

John Gagliardi has had success over the past 33 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. His career functions have included active involvement in the areas of research and development, quality assurance, operations, process architecture, training, and regulatory affairs. Over these years, John has specialized in building systems in these industries that not only seek compliance but also desire to be "business ready" and realize a profit. "Having a compliant quality system doesn't necessarily mean that your company has effective business systems as well."

 

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