At the International GMP Conference held virtually in early March 2021, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit provided five in-depth case studies from recent drug GMP inspections illustrating agency concerns and findings.
The GMP inspection case studies Barreto-Pettit provided include an in-depth analysis of the findings, lessons learned, and how companies can avoid similar shortcomings.
Redica Systems Senior GMP Quality Expert Jerry Chapman covered Barreto-Pettit’s presentation in five detailed articles. These articles have been compiled into a single complimentary PDF download.
To access this PDF, click here.
What You Will Learn
- The first countrywide import alert issued by FDA
- An inadequate deviation investigation
- An inadequate product specifications and a product recall
- Process validation issues at a CMO
- A different perspective on process validation and the culpability of the quality unit
About the Expert
Jerry Chapman is Redica Systems’s Senior GMP Quality Expert. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality roles. In corporate quality, he designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the US and internationally.
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