Definition, Documentation and Method Validation

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Definition

Documentation

Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 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

Pharmacy Technician Pulse

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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