Sample Size and Statistical Rationale for Medical Device Packaging Validations

Overview:
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 validation of 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

Who Will Benefit:
Packaging and quality Engineers
Managers
Packaging Technicians

Event Link: https://www.compliance4all.com/control/w_product/~product_id=500138LIVE/