Laboratory Investigations & Deviations

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
Conclusion
Final Assessment
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