Definition and Method Validation - Pharmacy Technician Pulse

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Definition

Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

As part of the change management process, personnel must manually find, view, and interpret the older data sets to establish a frame of reference for completing method validation exercises and compare the initial and optimized assays. IDMP Definition of Identification of Medicinal Products.” Published 15 September 2021.

Documentation

Documentation FDA Communication Packaging

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

The FDA Law Blog

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. Although data scientists sometimes refer to the tuning dataset as the validation dataset, FDA encourages using terminology consistent with the Agencys Artificial Intelligence Glossary. Update practices and training of end users also need to be addressed.

FDA

FDA Documentation Labelling Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

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