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:

• 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.

Tutors

Tutors will be comprised of (click the photos for biographies):

Tim Stiles

Consultant, Qualogy Ltd

Tony Woodall

Head of Quality Assurance, Alderley Analytical

Gill Armour

Study Monitor Team Leader, AstraZeneca

Jane Elliston

Senior Quality Assurance Auditor, Battelle UK

Vanessa Grant

-, -

Jeanet Logsted

CEO, Scantox

Programme

Please note timings may be subject to alteration.

Day 1

09:00

Registration

09:15

Welcome and Introductions

09:35

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

09:00

Questions and Answers

Discussion of issues raised by course delegates.

09:20

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