Medical Devices 2011 - Process Validation for Medical Device Manufacturers

The US FDA has required medical device manufacturers to validate certain production processes since the 1980's. Recently the Center for Devices and Radiological Health (CDRH) recognized the Global Harmonization Task Force (GHTF) guidance on Process Validation. They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices. This presentation 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 a 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?

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