Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
Deconstructing the Regulatory Spiral
Author(s)Russell Madsen
Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
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Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
Articles in this issue
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Measuring and Removing Genotoxic Impuritiesover 10 years ago
Qualification and Validation of Single-Use Shipping Systemsover 10 years ago
Lessons Learned Accelerate Vaccine Developmentover 10 years ago
Protecting the Product and the PatientAdvertisement
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