Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|October 2, 2002
- Pharmaceutical Technology-10-02-2002
- Volume 26
- Issue 10
FDA Launches Major Review of CGMPs
Author(s)Jill Wechsler
FDA is set to revise CGMPs to encourage new manufacturing technologies and develop improved agency policies to ensure drug quality and safety.
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Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
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