Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Wayne Taylor
OVERVIEW:
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:
How to link risk with the confidence statements associated with the sampling plans
Identify a variety of sampling plans, that all make the desired confidence statements
Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
Why should you Attend: In the medical device industry acceptance sampling plans are required for Validation/Verification/Effectiveness studies that must:
– Be based on a written procedure
– Aligns the plans to risk
– Provides a valid statistical rationale
Approaches and sources of such plans are explained and contrasted with manufacturing sampling plans
– Ensure compliance when selecting sample sizes
– Learn strategies for reducing sample sizes
– Learn strategies for avoiding false rejections
Areas Covered in the Session:
– Claims that can be made when passing a sampling plan
– How to select a sampling plan to make a specific claim
– Different types of sampling plans including single, double and variables
– How to reduce the number of units tested
– How to increase the chances of a good product/process passing a validation
– How to write protocols to handle contingencies so to avoid deviations
– Practical considerations including selecting representative samples
Who Will Benefit:
– Compliance Officer
– QA/QC Engineers and Management
– Process Engineers and Management
– Design Engineer and Management
– Regulatory and CAPA Personnel
– Statisticians
SPEAKER PROFILE:
Wayne Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
He is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for the development of the VarTran®, Change-Point Analyzer, Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics including Robust Design, Tolerance Analysis, Design of Experiments, Trending and Acceptance Sampling.
He is also author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. Dr. Taylor is a leading expert in Process Validation where he wrote Annex A of the Global Harmonization Task Force guideline titled Process Validation Guidance for Process Validation Engineers.
Dr. Taylor received his Ph.D. in Statistics from Purdue University where he is a distinguished alumnus. He is a fellow of the American Society for Quality, and recognized as one of 100 Notable People in the Medical Device Industry by MD&DI Magazine
