Good Laboratory Practices (cGLP)

Laboratory Investigations & Deviations

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.

CEU Credits: 0.1

Course Code: ELM-108

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Learning objectives

Who should take this course

Course modules

Module 1: Meaningful Investigations

Overview

Meaningful investigations

Definitions

Module 2: Regulatory Requirements

Overview

Regulatory requirements

EU cGMP

US GMP

ISO

cGLP

Guidance

Module 3: The Barr Decision

Overview

Barr decision

Barr decision - Barr's testing procedures

Findings of the court

Conclusions

Module 4: Conducting a Laboratory Investigation

Overview

What should be investigated?

Conducting a laboratory investigation

Phase 1(a) of the investigation - Identification of obvious errors

Phase 1(b) Investigation

Phase 1(b) Investigation Part 2

Phase 2 investigation

Retesting

Assessing the results from retesting

Investigation of stability out of specification and suspect results

Handling laboratory investigations

Phase 3 investigation

Review activity

Module 5: Documenting a Laboratory Investigation

Overview

Documenting laboratory investigations

Tracking laboratory investigations

Laboratory investigation case study

Laboratory investigation report

Information about the investigation

Description of event results in the investigation

Phase 1(a) investigation

Phase 1(b) of the investigation

Phase 2 investigation - Testing protocol

Phase 2 investigation findings

Phase 2 investigation - conclusion

Phase 3 of the investigation

Section 3 impact and disposition

Corrective and preventative action plan

Classification

Conclusion

Final Assessment

Certification

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd

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