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About us
Good Laboratory Practice Refresher and Hot Topics
Course Information
Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements and responsibilities and also to look at recent hot topics including trends and feedback from MHRA inspections.
The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance.
Is this course for you?
This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework.
Tutors
Tutors will be comprised of (click the photos for biographies):
Vanessa Grant
Tim Stiles
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Registration, Welcome and Introduction
09:20
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.
09:50
Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA
A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP.
10:30
Break
10:45
Workshop 1
Workshop 1 Roles and responsibilities
11:15
Influence of Sponsors
The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed.
11:45
Data Integrity
The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data.
12:30
Lunch
13:15
Quality Assurance and GLP
OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance
13:45
Quality Improvement Tools and GLP
The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022
14:15
Workshop 2
Workshop 2 Change control
14:30
Risk Assessment
How should we assess risk and how can we use the process to assist in evaluation audit findings?
15:00
Break
15:15
Current hot topics in GLP
Explore the current issues in Industry and trends /types of Regulatory inspection findings
15:50
GLP Clinic
An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance.
16:30
Close of Course
Extra Information
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.
Course Material
Course material will be available 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.
CPD Points
7 Points
Development Level
Learn
Recommended Products
A Practical Guide for the Good Laboratory Practice Study Director eBooklet
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory eBooklet
Advanced Good Laboratory Practice (GLP) elearning
Guide to the Role and Responsibilities of GLP Management eBooklet
Introduction to GLP Study Director Roles and Responsibilities
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet