The Basics of Laboratory Investigations

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Description:

The objective of Current Good Manufacturing Practices (cGMP) is to control the quality of pharmaceutical products, and therefore the purpose of laboratory investigations in a cGMP environment is to identify how adverse events that occur during the manufacture of products can impact on the safety, quality and efficacy of those products. During laboratory testing, sometimes out of specification (OOS), unexpected and suspect results are obtained. Events which cause a deviation from established laboratory procedures can also happen.

Curriculum for this course:

Program Introduction

Who Should Take This Program?	1 min 01 secs
Definitions	1 min 31 secs
References	1 min 21 secs

Course Overview

Learning Objectives	1 min 05 sec
Meaningful Investigations	1 min 10 secs
OOS and Unexpected Results	1 min 08 secs
Suspect Results and Laboratory Deviations	1 min 22 secs

Regulatory Requirements and Guidance

E.U. Regulatory Requirements on Laboratory Investigations	1 mins 29 secs
U.S. Regulatory Requirements on Laboratory Investigations	1 min 55 secs
ISO 17025	1 min 25 secs
cGLP Regulatory Requirements	1 min 10 secs
MHRA and FDA Guidance	1 min 38 secs
The Barr Decision: Overview	1 min 30 secs
The Barr Decision: Court Findings	1 min 11 secs
The Barr Decision: Conclusions	1 min 14 secs