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iSpeak Blog

Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process...

iSpeak Blog

Wow! You have been with the Society for 40 years! Can you give me a brief summary of your involvement with ISPE and share some of the more interesting experiences and successes you have had with the Society during your lengthy tenure?