In the second and last part of our two-part series in collaboration with KenX, industry expert Dr. David Vincent, CEO of VTI Life Sciences, breaks down about how to successfully implement a 2-stage process validation program in accordance with current international regulations. Viewers will learn how to implement process validation programs as well as the benefits associated with taking a science and risk-based approach.
What you can expect to learn:
- Utilizing technology transfer data from stage 1 to support development of CQAs and CPPs
- Facility and Equipment Design phase defining specifications for process instrumentation and software application used for controlling and monitoring
- Writing and documenting a user requirements specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)