Good Laboratory Practices (cGLP)

Performing Analytical Analysis in a Regulated Laboratory

This course discusses one of the most important topics in current Good Laboratory Practice for laboratory staff, that is, how to carry out and document your laboratory work in a compliant manner. When performing and documenting your work, it is important to remember that the laboratory records you create are the original and legal record of your work.

CEU Credits: 0.1

Course Code: ELM-109

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Course Introduction

Introduction

Overview

Learning objectives

Who should take this course

Course modules

Module 1: Study Plan and Test Preparation

Overview

Study plan

Sampling

Sample management

Control of laboratory reagents for use in testing

Management of laboratory reference standards

Module 2: Conduct of Analytical Testing

Overview

Conduct of analytical testing - Part 1

Conduct of analytical testing - Part 2

Conduct of analytical testing - Part 3

Conduct of analytical testing - Part 4

Conduct of analytical testing - Part 5

Weighing operations

Module 3: Test Solutions and Systems Suitability

Overview

Preparation of standard and analytical test solutions - Part 1

Preparation of standard and analytical test solutions - Part 2

Assuring standard accuracy

System suitability tests

System suitability - Chromatographic methods

Controlling chromatographic peak integration

Review activity

Module 4: Documentation and Review of Laboratory Testing

Overview

Reporting of test results

Rounding of numbers tie break rule

Documentation of laboratory testing

Ancillary data - Part 1

Ancillary data - Part 2

Review of laboratory testing

Module 5: Laboratory Records and Instrumentation

Overview

Requirements of laboratory records

Control of laboratory instrumentation

Review activity

Conclusion

Final Assessment

Certification

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd

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