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Quality Assurance for Good Laboratory Practice



If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance

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:

Cate Ovington
Director, The Knowlogy (Course Principal)

Jane Elliston
Senior Quality Assurance Auditor, Battelle

Shona Ross
Head of QA, Tower Mains


Recent Feedback

"I learned a lot and very much enjoyed the atmosphere! Thank you also for sharing so much of your knowledge."
"I found the course to be extremely beneficial and very well presented. I will most certainly be applying what I’ve learned to my day to day working practices."
"Very good and clear. Good presentation style and also found she had a more personal soft view on things as it is in real life (it's not just about following the OECD guidelines)."

CPD Points

14 Points

Course Programme

Please note timings may be subject to alteration


Day 1 

 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 
What is the role and responsibilities of QA in GLP.  Maintaining the independence of QA and what is an audit.
 10.30 Break 
 10.45 Standard Operating Procedures
GLP requirements and QA involvement.
 11.30 Study Plans
GLP requirements and QA involvement. 
 12.05  QA Programme
Risk based programme, what are Study, Process and Facility audits.
 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 - Feedback 
 15.45 The Auditor and Audit Conduct
Attitudes, attributes and techniques.
 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
A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value.
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
GLP Monitoring Authority 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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