Have you wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Learn from an expert who has helped companies manage through nearly 100 FDA inspections of foreign facilities around the world. Mr. Saxon will explain common findings, how to handle inspection observations, cultural issues that may be at play, and where the most serious issues are often found. His expertise could be of value to anyone who manages FDA inspections of foreign facilities.

 

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA 

 

Webinar Objectives
  • Where most regulatory problems are found by the FDA
  • How OAI (Other Action Indicated) results are categorized by the FDA and the ensuing consequences
  • What can be done to avoid these disappointing results
Seminar Information
Date Presented:
January 30, 2018 2:00 PM Eastern
Length:
1 hour
Managing Foreign Inspections/Foreign Supplier Inspections
Speaker Information
Peter Saxon  [ view bio ]
Individual topic purchase: Selected
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