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