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Research Quality Assurance for Good Laboratory Practice (GLP)

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Event Type

2 day, professional development training course

Recommended For

Auditors

Course Information

This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or working under Good Laboratory Practice regulation for the first time.

Benefits include

  • Sound regulatory basis for quality assurance activities
  • Clear understanding of the role of Quality Assurance, Management and Study Director under the Good Laboratory Practice principles
  • Improved inspections and audits
  • Improved Good Laboratory Practice compliance for your facility
  • An insight into government GLP monitoring activities

This course is structured to encourage delegates to

  • Discuss and develop ideas
  • Solve specific problems
  • Examine particular aspects of GLP

Course Programme

Day 1

8.55 Registration

9.00 Welcome and Introduction

9.15 Good Laboratory Practice Standards and Regulations

An insight into the background and history of Good Laboratory Practice.

9.45 Principles of Quality Assurance (1)

The role and responsibilities of QA.

10.30 Break

10.45 Principles of Quality Assurance (2)

The role and responsibilities of QA.

11.30 Study Plans

GLP requirements and QA involvement.

12.05 Standard Operating Procedures

GLP requirements and QA involvement.

13.00 Lunch

14.00 Inspections

Attitudes, techniques and attributes.

14.40 Workshop 1 – Facility and Process Inspections

An exercise in inspection planning and preparation for inspections.

15.15 Break

15.30 Workshop 1 – Continued

16.15 Workshop 1– Feedback

16.30 Panel Session

An opportunity for delegates to put questions to the panel of speakers.

17.15 Close of day

19.00 for 19.30 Course dinner

Day 2

9.00 Workshop 2 – A Mock Audit

10.45 Break

11.00 Workshop 2 – Feedback

11.30 Auditing the Study Report

Techniques and methods for the QA audit of the study report.

12.15 The Management of Raw Data, Record Keeping and Training Records (1)

  • The impact of GLP on data and records management
  • The use of computers in a GLP environment

12.45 Lunch

13.30 The Management of Raw Data, Record Keeping and Training Records (2)

14.15 Workshop 3 – Amendments to Study Plan and Deviations from the Plan

  • What are they?
  • What is the difference between them?
  • How are they controlled?

15.00 Workshop 3 – Feedback

15.15 Break

15.30 Regulatory Compliance

Government monitoring for compliance with Good Laboratory Practice.

16.15 Panel Session

An opportunity for delegates to put questions to the panel of speakers.

16.45 Close of course