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About us
Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
Course Information
Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments.
The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field.
Benefits of this course:
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Practical help and guidance on the interpretation and application of GLP
- An opportunity to update your knowledge of GLP with the current interpretation of requirements
- Access to an experienced panel of speakers
- Information on how other organisations address GLP issues
- An opportunity to improve your understanding of the GLP requirements as they are applied in different situations.
This course is structured to encourage delegates to:
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Discuss and develop ideas
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Solve specific problems
- Examine particular aspects of GLP
- Learn from the experience of others.
Tutors
Tutors will be comprised of (click the photos for biographies):
Tim Stiles
Tony Woodall
Gill Armour
Jane Elliston
Jane Elliston currently works for Battelle UK as a senior quality assurance auditor in GLP AgroChemical Residue and Environmental Fate Studies after more than 4 years as a consultant offering QA services in GLP, GCLP, GCP, GMP, ISO 9001, ISO 17025.
In her current role Jane conducts independent audits of facilities, studies and reports, and conducts customised training for staff.
Jane is a regular contributor to RQA Course and Conferences and received the RQA Award for Contribution to Industry in 2017.
Vanessa Grant
Jeanet Logsted
Programme
Please note timings may be subject to alteration.
Day 1
08:50
Registration
09:00
Welcome and Introductions
09:20
Development of Good Laboratory Practice
A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards.
09:50
Roles and Responsibilities
The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study.
10:20
Break
10:40
The Roles and Responsibilities of the Study Director and Test Facility Management
The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored.
11:10
Multi-site Studies
What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored.
11:50
Study Plan (Protocols)
GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed.
12:30
Lunch
13:15
Workshop 1 - The Study Plan
Some practical problems with study plans and amendments explored.
14:00
Workshop 1 - Feedback
14:15
Standard Operating Procedures
The control, content and authorisation of SOPs and the principles behind the practice.
15:00
Break
15:20
Workshop 2 - Practical Study Conduct Problems
Dealing with practical problems encountered during the conduct of studies.
16:00
Workshop 2 - Feedback
16:30
Close of Day
Day 2
09:00
Questions and Answers
Discussion of issues raised by course delegates.
09:20
Management of Raw Data and Records
A view on how records and materials are managed and archived in compliance with GLP.
10:00
Workshop 3 - Data and Sample Management Issues
Dealing with data and sample management issues.
10:45
Break
11:00
Workshop 3 - Feedback
11:30
Training Records
Which records need to be retained to demonstrate an individuals training and competence.
11:45
Quality Assurance
The interactions between QA, Management, Study Director and Principal Investigator are discussed as is QAs role when conducting a multi-site study.
12:15
The Final Report
The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained.
12:45
Lunch
13:30
Workshop 4 - Final Report Problems
Practical problems of report preparation including compliance statements.
14:15
Workshop 4 - Feedback
14:45
Regulatory Inspection
Government monitoring for compliance with Good Laboratory Practice.
15:15
Panel Session
This panel session will address any outstanding issues raised by delegates.
15:45
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
14 Points
Development Level
Develop
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
Introduction to Good Laboratory Practice (GLP) elearning
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet