Sample Size Justification & Statistical Analysis for Performance Qualification (PQ) Studies

Regulatory agencies mandate formal protocols for Performance Qualification (PQ) studies to determine whether products/processes meet the desired requirements. When planning PQ studies, sample size determination is critical to ensure that study results will be meaningful. Methods to determine appropriate sample sizes for various types of problems will be covered.

This 2-day seminar will provide a 12-step process to assist you in writing/reviewing protocols for PQ studies with a focus on sample size justification, acceptance criteria and statistical analysis using Minitab v17. Validation of software will not be covered.

Upon completing this course participants will be able to:

• Determine a Representative Sample for Process Qualification (PQ) study.
• Develop product/process acceptance criteria statements
• Determine appropriate Sample Size to meet PQ acceptance criteria
• Understand how to Analyze PQ data
• Understand how to calculate and interpret statistical tolerance limits
• Determine and verify the appropriate distribution of the data
• Interpret probability plots
• Apply normalizing transformations

This course is designed for people tasked with writing or reviewing Performance Qualification protocols. The following personnel will benefit from the course:

• Scientists
• Product and Process Engineers
• Quality Engineers
• Personnel involved in product development and validation
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners

Note: Use coupon code REFERRAL10 and get 10% off on registration.