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.

Date : 17th August 2017 to 18th August 2017

Place : United States, San francisco

Website :https://www.eventbrite.com/e/sample-size-justification-statistical-analysis-for-performance-qualification-studies-com-tickets-33512222961?aff=NDT

Contact Person:Paula Edwards

Description:

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.

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. will be held in San francisco,United States on date 2017-08-18

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Deadline for abstracts/proposals : 1st August 2017

Keynote Speakers : Jerry Phillips, M.S. Statistics, President and Founder, Phillips Statistical Consulting, LLC Jerry Phillips, M.S. Statistics, is the president and founder of Phillips Statistical Consulting, LLC. Jerry recently retired as Sr. Manager., Biostatistics, from Baxter Healthcare Corporation, a highly-regulated manufacturer and distributor of disposable infusion systems and hardware devices. During his 35+ year tenure, he participated on cross-functional teams that included engineering, manufacturing

Conference Highlights :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 Handle cen

Venue :San Francisco, CA, United States

Check the event website for more details.