2019 - Medical Devices - Complying With 820.250 Statistical Methods

Overview
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications.
Highlighted are statistical techniques for:
Process Validation
Design Verification
Design Validation
Audits and Effectiveness Checks
Test Method Validation
Manufacturing Acceptance Sampling Plans and Inspections
Trending Data
Setting Specifications
Numerous badly needed advances in the application of statistics have occurred over the last 10-20 years. This are highlighted including:
Change-Point Analysis for CAPA Investigations and Trending
Normalized I and Laney U charts for complaint trending
Equivalency testing instead of t-tests
Methods of Validating Attribute and Destruction Test Methods
Improved methods for testing for and handling nonnormal data
Sampling Plans for precision, accuracy, and homogeneity
Why should you Attend
Two of common 483 and Warning letter items are:
Lack of valid statistical rationale
Inadequate trending of Quality data
Learn how to avoid these and how to fully comply with the statistical regulations
The majority of 483s and Warning letters are associated with lack of or inadequate procedures. Every section of 820 that mentions statistics includes a reference to a procedure. Learn how to structure your statistical procedures to ensure compliance.
Areas Covered in the Session
Importance of a Statistical Policy
Needed procedures for areas of establishing, controlling and verifying
Important elements for each procedure
Valid statistical rational
Structuring the procedures to reduce the training burden
Deviating from procedures
Handling when there is not a procedure
Who Will Benefit
Corporate and Division Management
Regulatory Management and Personnel
Internal Auditors
QA/QC Engineers and Management
Process Engineers and Management
Design Engineer and Management
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