Sampling – Medical Devices

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This training is targeted to professionals concerned with a specific application of valid statistical techniques to satisfy Process Validation requirements of the FDA:s Quality System Regulation. Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then comes the age-old question: How much is enough?

SKU: 8009 Category: Tag:

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KEYcademy.com – On-demand Training

Does the US Food and Drug Administration (FDA) ever make a mistake? In the Preamble to the Quality System Regulation (21 CFR 820, Comment 85), they addressed sampling for Process Validation. Comment 85 says:

The requirement for testing from the first three production lots or batches has been deleted?. The number three is, however, currently considered to be the acceptable standard.

The FDA now admits that this guidance on a sample size of three is NOT statistically valid. They wish they could delete Comment 85 from the Preamble; however, to do this would take an act of the US Congress!

This training is targeted to professionals concerned with a specific application of valid statistical techniques to satisfy Process Validation requirements of the FDA:s Quality System Regulation. Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then comes the age-old question: How much is enough?

Content

  • Regulatory Context
  • Quality System Regulation 21 CFR 820 and Preamble Comments
  • GHTF Guidance for Process Validation
  • Significant Trends and Warning Letters
  • Demonstration of Best Practices
  • Estimating Process Capability
  • Graphical Tools
  • Common Pitfalls
  • Designing a Sampling Plan for New Production Processes
  • A Checklist Approach
  • Applying Statistical Methods and Tools
  • Sample Size Considerations
  • Applying Valid Statistical Software
  • Expressing a Risk-Based Decision

Duration: 2 hours

 

#8009

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