Eps 9 - The role of GAP analysis in successful FDA inspections скачать в хорошем качестве

Eps 9 - The role of GAP analysis in successful FDA inspections

In this episode, we talk with GxP consultant Christina Füting, Head of Experts Institut Austria, about FDA audits and the importance of GAP analysis. She explains what FDA audits typically involve, what inspectors look for, and how companies can prepare effectively. We also explore how GAP analyses help identify compliance gaps and improve audit readiness, along with common challenges and solutions. Your #ExpertsInstitut Our sources and further links can be found here: CFR - Code of Federal Regulations Title 21 https://www.ema.europa.eu/en/document... Guidance for Industry