Sample Size and Statistical Rationale - Contract Laboratory

Medical Device Packaging

Sample Size and Statistical Rationale

Live Webinar: April 28, 2016

Karen Greene, Life Packaging Technology LLC and Life Pack Labs, Vista, CA karen@ 760 835 2260

Life Packaging Technology and Life Pack Labs

Life Packaging Technology Provides customized packaging engineering services on a global basis: design, prototyping, technical and quality systems consultation and low volume manufacturing for packaging feasibility.



Life Pack Labs Provides expert packaging testing services for healthcare/ pharmaceutical and medical packaging



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Agenda

? Statistical Rationales---the importance and application of developing an appropriate sample size for testing

? Compliance and guidance for: ? medical device sterile barrier systems ? Food

? 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

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Statistical Sample Size Development

Why Have a Statistically Significant Sample Size?

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Why have a statistically significant sample size?

? For sterile medical devices? it is a requirement

? ISO 11607:2006, part 1--section 4.3- "The sampling plans used for selection and testing of packaging systems shall be applicable to the packaging systems being evaluated. Sampling plans shall be based upon statistically valid rationale"

? TIR ISO 16775 section 5.3: " Sampling plans should be acceptable to packaging systems, reflective of risk tolerance, and be based on statistically valid rationale".

? TIR ISO 16775 section 12.2.3, Packaging system design validation: "Sampling plan to be used: Sample sizes must be large enough to provide for statistically significant analysis to provide a high degree of reliability, and will be dependent on corporate risk policy, economics and regulatory requirements".

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Why have a statistically significant sample size?

? For Food? Food Safety and Modernization Act--2011 PREVENTION

? Written food safety plan? Includes:

? Evaluates hazards that are reasonably likely to occur (risk analysis)

? Steps put in place to minimize or prevent hazards--your mitigation

? Verification activities? might include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard

? Generally, cGMP provisions would still apply to facilities that would be exempt from the hazard analysis and riskbased preventive control requirements

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Statistical Sample Size Development

A Process for Development of a Statistical Rationale

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Statistical Sample Size Development

Risk Analysis

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