21 CFR Part 820 Subpart 0 – Statistical Techniques

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Description:

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.

Curriculum for this course:

Introduction

Overview	1 mins 10 secs
ISO, ICH and the FDA	1 min 30 secs
Program organization	1 min 25 secs
Program objectives	1 min 50 secs
Definition of a medical device	1 mins 11 secs
Class I, II and III	1 mins 33 secs
Intended use	1 mins 10 secs

History of 21 CFR Part 820

21 CFR 820 Timeline	1 min 50 secs
1906 – The Jungle	1 min 45 secs
1937 – Massengil Company	1 min 10 secs
1957 – Thalidomide	58 secs
1971 – Dalcon Corporation	1 min 48 secs
1990 – FDA device recall report	1 min 24 secs
A regulatory evolution	1 min 30 secs

Subpart O – Statistical Techniques

Course Introduction	1 min 20 secs
Learning Objectives	56 secs
Introduction	1 min 31 secs
Statistical Analysis	1 min 39 secs
Data Normality	1 min 10 secs
Data Normality – Statistical Tests	1 min 48 secs
Outliers	1 mins 23 secs
Outliers – Variability	1 mins 31 secs
Process Capability	1 mins 41 secs
Process Capability and Process Capability Index	1 min 01 secs
Process Capability Index and Process Performance Index	58 secs
The CpK	50 secs
Gage R&R	1 min 09 secs