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Basic Validation Statistics for Non - Statisticians

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.Areas Covered Introduction- What is Statistics- Why do you need Statistics for Validation?- Regulatory expectationsThe Concept of Variance (and why it is important)- Sources of variance- Measuring variance- Normal and non-normal distributions - Measuring Variance Expressing Variance- Variance- Standard deviation- Interactive exercise: Measuring Variance- Coefficient of variationProcess Capability- Can your system do what you want (need) it to do?- Measuring capability- Using capability to set acceptance criteria for validationConclusion and DiscussionWho Should AttendValidation engineers, R&D scientists, quality professionals and production personnel involved in validation activities. Why Should You AttendThis 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 is critical to evaluate a validation protocol prior to execution and to correctly interpret the data during and after the run. Topic BackgroundA basic understanding of statistics describing variation and how to measure it is fundamental to setting up a good validation program.

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.

Areas Covered

  • 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
    - Measuring Variance
  • 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 Should Attend

Validation engineers, R&D scientists, quality professionals and production personnel involved in validation activities. 

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 is critical to evaluate a validation protocol prior to execution and to correctly interpret the data during and after the run.

Topic Background

A basic understanding of statistics describing variation and how to measure it is fundamental to setting up a good validation program.