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.
Learning Objectives:
Upon completing this course participants will be able to:
Who will Benefit:
This course is designed for people tasked with writing or reviewing Performance Qualification protocols. The following personnel will benefit from the course:
Note: Use coupon code REFERRAL10 and get 10% off on registration.