Process Validation

US FDA’s Draft 2008 Process Validation Guidelines provide an excellent framework for understanding Process Validation . They describe the principles and approaches that the FDA feels the industry should use in executing...

Process Validation in Biotechnology Manufacturing (T32)

This training course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.