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Event Details


Medical Devices - Complying With 820.250 Statistical Methods

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Who should attend?

Corporate and Division Management Regulatory Management and Personnel Internal Auditors QA/QC Engineers and Management Process Engineers and Management Design Engineer and Management Statisticians



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




Joseph Wilcox

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