Laboratory Investigations & Deviations

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Description:

On completion of this course you will be able to, explain the elements of a meaningful laboratory investigation, define commonly used terms related to laboratory investigations, discuss the applicable cGMP/cGLP regulations and guidance related to laboratory investigations, explain the details and significance of the Barr Decision as it relates to laboratory investigations in acGMP/cGLP environment and explain the detailed procedure for all phases of conducting and documenting a laboratory investigation.

Curriculum for this course:

Introduction

Overview	2 mins 11 secs
Learning objectives	1 min 34 secs
Who should take this course	1 min 12 secs
Course modules	1 min 34 secs

Module 1: Meaningful Investigations

Overview	1 min 15 secs
Meaningful investigations	1 min 50 secs
Definitions	1 min 25 secs

Module 2: Regulatory Requirements

Overview	45 secs
Regulatory requirements	1 min 55 secs
EU cGMP	1 min 15 secs
US GMP	1 min 10 secs
ISO	1 min 17 secs
cGLP	1 min 41 secs
Guidance	1 min 22 secs

Module 3: The Barr Decision

Overview	50 secs
Barr decision	1 min 07 secs
Barr decision – Barr's testing procedures	1 min 48 secs
Findings of the court	1 min 17 secs
Conclusions	39 secs

Module 4: Conducting a Laboratory Investigation

Overview
What should be investigated?	1 min 10 secs
Conducting a laboratory investigation	49 secs
Phase 1(a) of the investigation – Identification of obvious errors	1 min 27 secs
Phase 1(b) Investigation	1 min 17 secs
Phase 1(b) Investigation Part 2	1 min 59 secs
Phase 2 investigation	1 min 01 secs
Retesting	1 min 16 secs
Assessing the results from retesting	1 min 27 secs
Investigation of stability out of specification and suspect results	1 min 38 secs
Handling laboratory investigations	1 min 49 secs
Phase 3 investigation	1 min 54 secs
Review activity	5 mins

Module 5: Documenting a Laboratory Investigation

Overview	1 min 54 secs
Documenting laboratory investigations	1 min 24 secs
Tracking laboratory investigations	58 secs
Laboratory investigation case study	1 min 44 secs
Laboratory investigation report	1 min 10 secs
Information about the investigation	1 min 38 secs
Description of event results in the investigation	51 secs
Phase 1(a) investigation	1 min 41 secs
Phase 1(b) of the investigation	1 min 30 secs
Phase 2 investigation – Testing protocol	1 min 49 secs
Phase 2 investigation findings	1 min 39 secs
Phase 2 investigation – conclusion	1 min 44 secs
Phase 3 of the investigation	1 min 41 secs
Section 3 impact and disposition	1 min 20 secs
Corrective and preventative action plan	1 min 10 secs
Classification	46 secs