ICH Q9

Training
The new FDA Guidance for Industry on Process Validation states that “activities undertaken to demonstrate utilities and pieces of equipment are suitable for their intended use and perform properly is referred to as...
Training
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging,...
Training
This fundamental online course will help you understand the “why” what,” and “how to use” the ISPE Baseline® Guide, Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP). Risk-MaPP provides a scientific risk...
Guidance Docs
Guidance for Industry, Q9 Quality Risk Management U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...