Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

Instructor: John N Zorich
Product ID: 706189
Training Level: Intermediate
  • Duration: 90 Min
This webinar provides guidance on how to justify sample sizes, and thereby indirectly provides guidance on how to choose sample sizes. Those justifications can then be documented in Protocols or regulatory submissions or can be given to regulatory auditors who may ask for them during onsite audits at your company. Thus, this webinar is designed to help you avoid regulatory delays in product approvals and to prevent an auditor from issuing you a nonconformity.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2019

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

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Read Frequently Asked Questions

Why Should You Attend:

Almost all manufacturing and development companies perform at least some verification testings or validation studies of design-outputs and/or manufacturing processes, but it is sometimes difficult to explain the rationale for the sample sizes used in such efforts. This webinar provides the training in how to make and word such rationales.

NOTE: This webinar does not address rationales for sample sizes used in clinical trials.

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size. The statistical methods discussed during the webinar include the following:

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

QC Sampling Plans.

Areas Covered in the 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 Calculations
      • ** 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

Who Will Benefit:

  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

From Design/manufacturing in the Medical Device and Pharmaceutical Industries, and other associated companies.

Instructor Profile:
John N Zorich

John N Zorich
Statistical Consultant and Trainer, Statistical Consultant

John Zorich has spent almost 40 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the next 15 years were as a consultant in the areas of QA/QC and Statistics. These last few years were as a trainer and consultant in the area of Applied Statistics only. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. His experience as an instructor in applied statistics includes having given annual 3-day seminars for many years at Ohlone College (San Jose CA), and previously having given that same course for several years for Silicon Valley ASQ Biomedical. He's given numerous statistical seminars at ASQ meetings and conferences. And he creates and sells validated statistical software programs that have been purchased by more than 110 companies, world-wide.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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