Senior Technical Manager for Corporate Quality and Validation at Genentech, Inc.
Process Lifecycle Validation: Applying Risk Management
The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2
Need a standard to follow? Just ask, What would Genentech do?
Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 1
Best practices from Big Biotech, including how to handle new product introductions.