Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|March 1, 2002
- Pharmaceutical Technology-03-02-2002
- Volume 26
- Issue 3
Drug Safety Concerns Shape Manufacturing Policy
Author(s)Jill Wechsler
FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.
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Articles in this issue
over 24 years ago
Outsourcing Outlookover 24 years ago
Developing Custom Adhesive Systems for Transdermal Drug Deliveryover 24 years ago
PDA Task Force Issues Guidelines to Aid Isolator Usersover 24 years ago
Production Information Mangementover 24 years ago
Validation Changes to the USP Assay Method for Ibuprofen Tabletsover 24 years ago
Systematic Troubleshooting for LC/MS/MSAdvertisement
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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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