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)
CEO, Scantox A/S
Senior Quality Assurance Auditor, Battelle
Study Monitor, AstraZeneca
"In general, alls three tutors were friendly and enthusiastic. It was clear the huge experience they have on all aspects of GLP studies, including and specially from the practical side. That helps a loT to better understand the implications, (real) problems and (real) solutions."
"Highly appreciated feedback on digital slide archiving, nice presentations, very friendly, helpful answers"
"We had very helpful discussions throughout the whole course, both in the workshops but also after each presentation. all tutors mentioned their point of view. this makes clear that there is not always one correct answer to a GLP question, but brings me little more into a better thinking and understanding about GLP and its principles."
Please note this course will run in UK timezone.
|9.00||Welcome and Introductions|
|9.20||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.
|9.50||Roles and Responsibilities
The responsibilities of Study Director, Test Facility, Management and study staff in the conduct of a GLP study.
|10.45||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.
|12.15||Study Plan (Protocols)
GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed.
|13.30||Workshop 1 - The Study Plan
Some practical problems with study plans and amendments explored.
|14.30||Workshop 1 - Feedback|
|14.45||Standard Operating Procedures
The control, content and authorisation of SOPs and the principles behind the practice.
|15.35||Workshop 2 - Practical Study Conduct Problems
Dealing with practical problems encountered during the conduct of studies.
|16.30||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|
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.
You will need a stable internet connection, a microphone and a webcam.
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
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P32 Process Mapping and SOP Writing
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING