Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|March 15, 2021
- Pharmaceutical Technology-03-15-2021
- Volume 2021 eBook
- Issue 1
Regulatory and Standard Setting Organizations Directory
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
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Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Articles in this issue
over 5 years ago
It Takes a Bio/Pharma Villageover 5 years ago
Managing the Risk of Nitrosamine Impuritiesover 5 years ago
Collaborative Efforts Address Key Data Integrity Challengesover 5 years ago
Can FDA Reinvent Inspectionsover 5 years ago
FDA 2021 Guidance Agenda Sees Focus on Genericsover 5 years ago
A Real-World Approach to Evaluating Cleanroom Garmentsover 5 years ago
Resources, Guidelines, and Guidance Documents DirectoryAdvertisement
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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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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
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FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
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