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Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management

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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
Director of QA EMEA, Envigo

Jeanet Løgsted
Director of Toxicology Operations, CiToxLAB Scantox

Jane Elliston
Quality Consultant, Headway Quality Evolution

Gillian Armour
Team Leader, Envigo

MHRA

Recent Feedback

"Loved the conversational style (experienced instructors know how to use powerpoint to aid a presentation rather than relying on it) and the consistent inclusion of just enough humour to keep us engaged without being overbearing. "

CPD Points

14 Points

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)

Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

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

9.20 Questions and Answers
Discussion of issues raised by course delegates.
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

 

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Recommended Products

Booklets

A Practical Guide to GLP in the Analytical Laboratory Booklet
Guide to the Role and Responsibilities of GLP Management Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P32 Process Mapping and Using Maps in Standard Operating Procedures Writing

eLearning Products

Advanced Good Laboratory Practice (GLP) elearning
Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning

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