This Process validation training/webinar for medical device manufacturers will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.
Areas Covered in the seminar:
How does the US FDA interpret the GHTF guidance document?
Why should company validate production processes?
What processes require validation?
How does Process Validation relate to Design Validation?
How does Process Validation relate to Six Sigma and SPC methods?
What type of statistical tools are needed to conduct Process Validation?