Communication, Definition and Method Validation

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Communication

Definition

Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies. IDMP Definition of Identification of Medicinal Products.”

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

Stay Connected