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.

Book a Demo

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

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

Conclusion

Final Assessment

Certification

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learn More

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Learn More

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.

Learn More