Statistical Methods For Process Validation

🎤  Alan M. Golden        |  📅  Recording Available   |  🕒  60 Minutes

Description: 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 in the Session:  

• 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: 

• Quality Assurance Professionals
• R&D Scientists
• Technical Support Scientists
• Regulatory Affairs Professionals
• Manufacturing and Production Personnel involved in validation activities