21 CFR Part 820

21 CFR Part 820 Subpart 0 – Statistical Techniques

By the end of this course you will have learned, how each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics and how when sampling plans, when used, shall be written and based on a valid statistical rationale.

CEU Credits: 0.1

Course Code: ELM-315

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

ISO, ICH and the FDA

Program organization

Program objectives

Definition of a medical device

Class I, II and III

Intended use

History of 21 CFR Part 820

21 CFR 820 Timeline

1906 – The Jungle

1937 – Massengil Company

1957 – Thalidomide

1971 – Dalcon Corporation

1990 – FDA device recall report

A regulatory evolution

Subpart O - Statistical Techniques

Course Introduction

Learning Objectives

Introduction

Statistical Analysis

Data Normality

Data Normality – Statistical Tests

Outliers

Outliers – Variability

Process Capability

Process Capability and Process Capability Index

Process Capability Index and Process Performance Index

The CpK

Gage R&R

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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