Sample size and statistical rationale for medical device packaging

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Live Webinar Sample Size and Statistical Rationale for Medical Device Packaging Validations Date: Wed, December 10, 2014 Instructor: Karen Greene

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

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Location: Online

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: ยก Medical device sterile barrier systems Determining sample size for sterile barrier systems (packaging systems) ยก 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

About Speaker Karen Greene Vice President, Life Packaging Technology LLC Karen is currently Vice President, Life Packaging Technology LLC, a packaging.

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