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Quality Assurance for Good Laboratory Practice



Course Information

This course is essential for all Quality Assurance auditors just stepping out or developing their role in a GLP environment, and provides expert insight and guidance in developing a robust and effective GLP audit programme.

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 Tutors

Tutors will be comprised from the list below:

Roger Chapman
Director, Chapman QA Ltd (Course Principal)

Jane Elliston
Quality Consultant, Headway Quality Evolution

Christina Olsen-Sundelin


Recent Feedback

"Great presenter, easy to listen to and enjoyed the real world examples."
"Great presenter, really got me thinking about things"

CPD Points

14 Points

Course Programme

Please note timings may be subject to alteration


Day 1 

8.55 Registration 
 9.00 Welcome and Introductions 
 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 

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. 
 12.00 Record Keeping and Data
The impact of GLP on data and records management.
 12.40 Lunch 
13.25  Data Integrity
An insight into the murky world of fraud, falsification, malpractice and various other points of view... And a look at the MHRA draft GxP guidance document
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 


Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.


You will also receive a copy of our booklet - "A Practical Guide to GLP Quality Assurance"

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). 
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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Recommended Products


A Practical Guide to GLP Quality Assurance
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Guide to the Role and Responsibilities of GLP Management
Hosting an External GLP Inspection
Management of the Training and Competency of Personnel in GxP and Research Environments


P01 Introduction to Computer Systems Validation
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P08 The Auditing Course
P16 Good Laboratory Practice Refresher
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

eLearning Products

Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to the Audit Process elearning