Validation Statistics for Non-Statisticians


Instructor: Alan M Golden
Product ID: 706944
Training Level: Intermediate

  • Duration: 60 Min
In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.
Last Recorded Date: Jan-2024


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Why Should You Attend:

This webinar will be useful to validation engineers, R&D scientists, quality professionals and production personnel involved in validation activities. Validation professionals in both medical device and pharmaceutical industries will benefit.

A basic understanding of statistics and the application to validation is vital to anyone involved in validation activities

Areas Covered in the Webinar:

  • Introduction
    • What is Statistics?
    • Why do you need Statistics for Validation?
    • Regulatory expectations
  • The Concept of Variance (and why it is important)
    • Sources of variance
    • Measuring variance
    • Normal and non-normal distributions
  • Expressing Variance
    • Variance
    • Standard deviation
    • Interactive exercise: Measuring Variance
    • Coefficient of variation
  • Process Capability
    • Can your system do what you want (need) it to do?
    • Measuring capability
    • Using capability to set acceptance criteria for validation
    • Conclusion and Discussion

Who Will Benefit:

  • Quality Assurance Professionals
  • R&D Scientists
  • Technical Support Scientists
  • Regulatory Affairs Professionals
  • Manufacturing and Production Personnel involved in validation activities
Instructor Profile:
Alan M Golden

Alan M Golden
Principal, Design Quality Consultants

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).




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