This course is designed to introduce the US-FDA cGMP regulations and how they impact all aspects and levels of a pharmaceutical or biotech organization. The course presents a high-level overview of medical device, drug, biologics and combination products cGMP regulations as well as how these regulations go beyond product “manufacture”. Concepts such as validation, stability, auditing, change control, non-conformities, CAPA, SOPs, complaints and recalls are introduced and discussed.
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