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FDA Inspections are Different from ISO Audits, So Don’t Treat Them the Same

Wednesday, June 14
2:45 pm – 4:00 pm
Room 49



John Gagliardi

MidWest Process Innovations




ISO audits and FDA inspections differ logistically, and should be approached in different manners. This session will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered. Time will be left for “What if?” and “Then what?” discussions.


Attendee Takeaways

  1. Overview of the differences between an audit and an inspection
  2. Strategies for each step, from preparation to follow-up
  3. Applicable examples with actionable advice


John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner.

Helpful links: What if Your ISO Auditor is Wrong? | How to Avoid Major FDA Inspection Mistakes