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.
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
Course Provider
Alan M Golden,
