Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|August 2, 2001
- Pharmaceutical Technology-08-02-2001
- Volume 25
- Issue 8
Changes and Challenges for CDER
Author(s)Jill Wechsler
The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.
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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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The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
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