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Subscribe NewsletterProcess Validation for Medical Device Manufacturers
Product Id
:
600098
Overview: All medical device companies are required to review its manufacturing processes to determine which processes require process validation, and which processes may be qualified by other methods.
The FDA enforces these requirements through its inspection program, and in the last few years well over 1/3 of all inspection observations have occurred in production and process controls. Many of these observations have cited companies for failure to perform adequate process validation.
The FDA enforces these requirements through its inspection program, and in the last few years well over 1/3 of all inspection observations have occurred in production and process controls. Many of these observations have cited companies for failure to perform adequate process validation.
Areas Covered in the Session:
- 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?
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Managers
- Quality Engineers
- Production Management