Conference about Sample Size and Statistical Rationale for Medical Device Packaging Validations

Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.

Areas Covered in the Session:

• Statistical Rationales-the importance and application of developing an appropriate sample size for testing
• Compliance and guidance for:
  • Medical device sterile barrier systems
• Determining sample size for sterile barrier systems (packaging systems)
  • A process for developing an appropriate and statistically valid test population
• Summary of key takeaways of non-statistically significant survey of medical device companies on statistical rationales
• Wrap Up
• Question and answer

• Packaging and Quality Engineers
• Packaging and Quality Managers
• Test Engineers