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1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation

1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation
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Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Workshop (April 24-25, 2023)

/PRNewswire/ The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Workshop" training has been added to. ....

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Final Weeks to Register for the Latest Process Validation Guidance Requirements Course: FDA and EU Annex 15 Qualifications and Validation (March 22-23, 2023)

/PRNewswire/ The "Latest Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to. ....

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Replacing The MACMACO With The MSC Rethinking How Cleaning Validation Limits Are Calculated

Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe. ....

United States , Henry Hank Avallone , Mariann Neverovitch , Ester Lovsin Barle , Alfredo Canhoto , Osamu Shirokizawa , Christophe Gamblin , Ajay Kumar Raghuwanshi , Andreas Flueckiger , Davidg Dolan , Hongyang Li , Gabriela Cruz , Siegfried Schmitt , Ioana Gheorghiev , Igor Gorsky , Mohammad Ovais , Joel Bercu , Ersa Yuliza , James Agalloco , Mallory Degennaro , Susan Jansen Varnum , James Bergum , Ioanna Maria Gerostathes , Andrew Walsh , Jessica Graham , Ralph Basile ,

Are You Approaching LIMS Validation Correctly

Are You Approaching LIMS Validation Correctly?
Laboratory information management systems (LIMS) are an established part of larger laboratories. While all LIMS are based on the application of information to improve laboratory productivity, efficiency, and compliance, different systems vary in their scale, functionality, and quality. It is important that systems are appropriately validated, for it does not matter how good a system is if the validation is not conducted to an applicable standard. For example, errors can occur in terms of tracking data associated with samples, or acceptance criteria may be attributed to the wrong sample.
This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory. ....

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