Good Laboratory Practices (cGLP)

How to Prepare for Internal & External Laboratory Audits

This course will examine the formal laboratory audit from the perspective of the laboratory being audited. By the end of this course you will be able to explain, the different approaches the auditor can follow during an audit, the things the auditor will be looking for during a typical laboratory audit, an overview of a strategy the laboratory can use to handle audits, what the laboratory can do to prepare for the audit, how to handle the progress of an audit, how to follow up after completion of an audit and what constitutes obstructing regulatory audits

CEU Credits: 0.1
Course Code: ELM-106
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning objectives
Who should take this course
Module overview
Overview
Approaches to audits
How audits are usually performed
Strategy for handling formal audits
Overview
The question on permitting photography, video and sound recordings
Policy of the use of photography, video and sound recording during audits
What documents should be shown to the inspectors
Documents that should not be reviewed
Review activity
Overview
Roles of staff directly involved in the audit
What will the inspectors audit
Review of laboratory investigations and deviations
Study and testing plans
Sample management
Reference standards
Laboratory instrumentation
Laboratory operations
Overview
Maintaining audit readiness
Commonly requested items
Role of the audit coordinator
The operations center
During the audit - opening meeting
Documentation
Answering auditors questions
Tour of the laboratory and facility
Exit meeting
Review activity
Overview
Audit follow-up
Obstructing regulatory audits
Acceptable explanations
Key points moving forward

Conclusion

Final Assessment

Certification

Redesigned course with new Articulate Storyline player
V2.0
Added new Review Activities
V2.0
Added new final exam question to align with learning objectives
V2.0
Updated Glossary links
V2.0

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd

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