Conference
Thursday, June 5, 2008
9:00 A.M. - 4 P.M.
| Session 400 - Advanced Good Manufacturing Practices-----21 CFR, Part 820 |
Instructors: 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
|
ABOUT THE INSTRUCTORS
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."
|
