Medical Devices 2012 - Medical Device Process Validation - Statistical Considerations

This Process Validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
The FDA’s Quality system regulation requires device manufacturers to validate processes when they don’t fully verify the resulting output. Based on Warning Letters, the FDA expects manufacturers to validate processes when the output check uses sampling instead of 100% inspection.
Why Should You Attend:
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result ? processes that produce only conforming material. This is the essence of the statistical approach.
Areas Covered in the Seminar:
- QMS Requirements for Process Validation.
- FDA’s QSR (21 CFR §820.75)
- ISO 13485:2003
- The Statistical Process Model.
- Relating input to output
- The Process Output.
- Sampling Inspection
- Process Capability
- The Process Input Parameters.
- Design of Experiments
- The Challenge Points
- Risk Management.
- Production Information
- Validated Processes as High Risk