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About us
Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
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 designed to provide comprehensive guidance and practical help for those who fulfil the role of Study Director or Principal Investigator in the conduct of non-clinical safety studies on pharmaceuticals, agricultural and industrial chemicals in compliance with Good Laboratory Practice (GLP). This course will also be of considerable benefit to study staff and management working in a GLP environment. The course will address current OECD GLP Principles and UK GLP legislation, but will also make reference to other international standards, regulations and guidelines.
Benefits include
- 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
- Discuss and develop ideas
- Solve specific problems
- Examine particular aspects of GLP
- Learn from the experience of others
Course Tutors
Tutors will be comprised from the list below:
Tim Stiles
Consultant, Qualogy Ltd (Course Principal)
Peter Davies
Consultant, Peter Davies Associates (Course Principal)
Vanessa Grant
Jeanet Løgsted
CEO, Scantox A/S
Jane Elliston
Senior Quality Assurance Auditor, Battelle
Gillian Armour
Study Monitor, AstraZeneca
MHRA
Recent Feedback
"Really enjoyed the content of the course, structure of the sessions and workshops and the tutors were great. All the Powerpoints were clear and informative, learnt a lot!"
"Workshops organised to ensure delegates interacted with as many of the others as possible. Trainers were from varied backgrounds so were able to share their experiences."
"The workshops were a great way to see how people from different organisations would approach different issues."
CPD Points
14 Points
Course Programme
Please note timings are subject to alteration
Day 1 |
|
| 9.00 | Registration |
| 9.15 | Welcome and Introductions |
| 9.35 | 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. |
| 10.05 | Roles and Responsibilities The responsibilities of Study Director, Test Facility, Management and study staff in the conduct of a GLP study. |
| 10.45 | Break |
| 11.00 | 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. |
| 11.45 | 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. |
| 12.30 | Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. |
| 13.00 | Lunch |
| 13.45 | Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. |
| 14.45 | Workshop 1 - Feedback |
| 15.00 | Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. |
| 15.30 | Break |
| 15.45 | Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. |
| 16.40 | Workshop 2 - Feedback |
| 17.15 | Close of day |
Day 2 |
|
| 9.00 | Questions and Answers Discussion of issues raised by course delegates. |
| 9.20 | Quality Assurance The interactions between QA, Management, Study Director and Principal Investigator are discussed as is QAs role when conducting a multi-site study. |
| 10.00 | 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. |
| 10.30 | Break |
| 10.45 | Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. |
| 11.30 | Workshop 3 - Feedback |
| 12.00 | Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. |
| 12.45 | Lunch |
| 13.30 | Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. |
| 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 |
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.
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.
Recommended Products
Booklets
A Practical Guide for the Good Laboratory Practice Study Director
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Guide to the Role and Responsibilities of GLP Management
Management of the Training and Competency of Personnel in GxP and Research Environments
Courses
P04 Quality Assurance for Good Laboratory Practice
P32 Process Mapping and SOP Writing
RP05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
eLearning Products
Advanced Good Laboratory Practice (GLP) elearning
Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning
