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.
Tutors will be comprised from the list below:
Consultant, Qualogy Ltd (Course Principal)
Consultant, Peter Davies Associates (Course Principal)
Associate Director, AstraZeneca
General Manager, Charles River Copenhagen A/S
Quality Consultant, Headway Quality Evolution
Study Monitor, AstraZeneca
"Very good discussions and points and successful with the workshops to actually see how different people interpret the same set of rules"
"All three tutors were brilliant. Their GLP knowledge was second to none. They were really friendly and approachable (despite being leaders in their field) and at no point did I feel nervous about asking even the simplest question."
"The course was explained very well, the tutors made sure that everyone understood the material before moving on and all questions were answered and explained."
"The workshops were very good, making you think about all the different scenarios and not having just a single answer."
"Very useful for updating knowledge. with regs not changing but expectation changing faster than business processes can keep up. Will be making quite a few suggestions to my facility management/QA."
Please note timings are subject to alteration
|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.
|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.
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.
|13.45||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.
|15.45||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|
|9.00||Questions and Answers
Discussion of issues raised by course delegates.
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.
|10.45||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.
|13.30||Workshop 4 - Data and Sample Management Issues
Dealing with data and sample management issues.
|14.15||Workshop 4 - Feedback|
Government monitoring for compliance with Good Laboratory Practice.
This panel session will address any outstanding issues raised by delegates.
|15.45||Close of course|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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.
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.
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
P04 Quality Assurance for Good Laboratory Practice
P14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
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