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

Description

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.

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

Consultant, Qualogy Ltd

Head of Quality Assurance, Alderley Analytical

Study Monitor Team Leader, AstraZeneca

Senior Quality Assurance Auditor, Battelle UK

-, -

CEO, Scantox

Please note timings may be subject to alteration.

Registration

Welcome and Introductions

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.

Roles and Responsibilities

The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study.

Break

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.

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.

Study Plan (Protocols)

GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed.

Lunch

Workshop 1 - The Study Plan

Some practical problems with study plans and amendments explored.

Workshop 1 - Feedback

Standard Operating Procedures

The control, content and authorisation of SOPs and the principles behind the practice.

Break

Workshop 2 - Practical Study Conduct Problems

Dealing with practical problems encountered during the conduct of studies.

Workshop 2 - Feedback

Close of Day

Questions and Answers

Discussion of issues raised by course delegates.

Quality Assurance

The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study.

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.

Break

Workshop 3 - Final Report Problems

Practical problems of report preparation including compliance statements.

Workshop 3 - Feedback

Management of Raw Data and Records

A view on how records and materials are managed and archived in compliance with GLP.

Lunch

Workshop 4 - Data and Sample Management Issues

Dealing with data and sample management issues.

Workshop 4 - Feedback

Regulatory Inspection

Government monitoring for compliance with Good Laboratory Practice.

Panel Session

This panel session will address any outstanding issues raised by delegates.

Close of Course

Face-to-face course

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

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.

Remote 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.

14 Points

Develop