A Costly But Valuable Lesson in STATISTICAL RATIONALES for Sample Sizes

Almost all manufacturing and development companies perform at least some verification testings or validation studies of design-outputs and/or manufacturing processes. This much is known and is simple to understand, but what is not, and is sometimes tough to explain, is the rationale for the sample sizes used in such efforts.

A key, 120-minute learning session from Compliance4All, a leading provider of compliance training for all the areas of regulatory compliance, will offer vital guidance on how to justify such sample sizes, which paves the way for an understanding of how to choose sample sizes.

The valuable lesson that this session, which will be taught by the highly accomplished John N. Zorich, a senior professional in the medical device manufacturing industry, will help document those justifications in protocols or regulatory submissions. This documentation can also be used to be given to regulatory auditors who may ask for them during onsite audits at your company. To enroll for this highly educative learning, which will be organized on April 24, and is of two hours’ duration, please visit https://t2m.io/q9uLU8me

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At this webinar, John will explain the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and will describe the ways by which to express a valid statistical justification for a chosen sample size. This webinar will be a valuable lesson in valid statistical rationales for sample sizes and is designed to help its participants avoid regulatory delays in product approvals. It will also protect them from an auditor issuing them a nonconformity.

These are the statistical methods that the expert will discuss during the webinar:

• Confidence intervals
• Process Control Charts
• Process Capability Indices
• Confidence/Reliability Calculations
• MTBF Studies ("Mean Time Between Failures" of electronic equipment)
• QC Sampling Plans

Participants are requested to note that this webinar is about valid statistical rationales for sample sizes for manufacturing and development companies, but does not address rationales for sample sizes used in clinical trials.

This session is aimed at benefiting professionals whose work involves statistical rationales for sample sizes, such as QA/QC Supervisor, Process Engineer, Manufacturing Engineer, QA/QC Technician, Manufacturing Technician, and R&D Engineer. John will cover the following areas at this webinar:

• Introduction
  • Examples of regulatory requirements related to sample size rationale
  • Sample versus Population
  • Statistic versus Parameter
• Rationales for sample size choices when using
  • Confidence Intervals
    • Attribute data
    • Variables data
  • Statistical Process Control C harts (e.g., XbarR)
  • Process Capability Indices (e.g., Cpk)
  • Confidence/Reliability Calculation
    • Attribute data
    • Variables data (e.g., K-tables)
  • Significance Tests (using t-Tests as an example)
    • When the "significance" is the desired outcome
    • When "non-significance" is the desired outcome (i.e., "Power" analysis)
  • AQL sampling plans
• Examples of statistically valid "Sample-Size Rationale" statements.

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About the expert: During his over four decades in the medical device manufacturing industry; John has been everything from an employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory areas, to a consultant in the areas of QA/QC and Statistics, to a consultant and trainer in the area of Applied Statistics.

Apart from giving numerous statistical seminars at ASQ meetings and conferences, John has created and sold validated statistical software programs that have been purchased by more than 110 companies around the globe.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.