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Good Laboratory Practice Refresher and Hot Topics REMOTE LEARNING



REMOTE LEARNING - this course will be delivered to you live online from the UK. 

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

Course Information

The course is aimed at providing a reminder and refresh of the key GLP requirements and responsibilities including Data Integrity and also to look at recent hot topics and trends including feedback from MHRA Inspections. Specific areas covered include Risk Assessment and the OECD guidance on Sponsor Influence and OECD Advisory on QA.   The programme also includes a GLP clinic where any issues raised by the delegates regarding understanding and maintaining GLP Compliance can be discussed.

The course is aimed at Study Directors, Principal Investigators, Test Facility Management and QA.

Course Tutors

Tutors will be comprised from the list below:

Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd

Vanessa Grant

Recent Feedback

"Tim's presentation was comprehensive and covered a wide range of topics relevant to my role as a SD. Tim gave valuable information when replying to questions during the presentation."
"Good and lively presentations, very nice prepared slides and able to provide feedback on any question raised."
"Tim presented the story in a way that was encouraging to deeper thoughts about the topic and to develop a wider discussion. It was really nice to have him as a tutor."


CPD Points

7 Points

Course Programme 

Please note this course will run in UK timezone.

 9.00 Registration 
  Welcome and Introduction 
 9.15 Development of Good Laboratory Practice
A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards as well as possible impact of Brexit. 
 9.45 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA
A reminder of the role of the Study Director in the management and control of a study, as defined by GLP, and Management’s roles are explored.
 10.30 Break 
 11.00 Data Integrity 
With the publication of the MHRA Guidance document on Data Integrity has the challenge changed? 
The responsibilities of Study Director, Test Facility Management and study staff in ensuring the integrity of the GLP study data. 
Including exploring the practical issues of assuring data integrity. 
 11.45 Influence of Sponsors
The recently published OECD Position Paper Number 21 regarding Possibly Influence of Sponsors on Conclusions of GLP Studies is reviewed and discussed.. 
 12.45 Lunch 
 13.45 Risk Assessment
How should we assess risk and how can we use the process to assist in evaluation audit findings.
14.15  Test Item Requirements
What are the new requirements from OECD No.19 and what are the expectations on the Study Director /Principal Investigator and Test Facility Management.
 14.35 GLP Clinic 
A chance to discuss your own issues. 
 15.15 Break
 16.00 Current Hot Topics in GLP
Explore the current issues in Industry and trends /types of Regulatory inspection findings 
16.30 Close of day 


Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

Please note this course will run in UK timezone.

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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