Good Laboratory Practice Refresher and Hot Topics

Description

Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections.

The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance.

This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework.

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

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Consultant, Qualogy Ltd

Please note timings may be subject to alteration.

Registration, Welcome and Introduction

Development of Good Laboratory Practice

A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards.

Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA

A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP.

Break

Workshop 1

Workshop 1 Roles and responsibilities

Influence of Sponsors

The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed.

Data Integrity

The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data.

Lunch

Quality Assurance and GLP

OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance

Quality Improvement Tools and GLP

The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022

Workshop 2

Workshop 2 Change control

Risk Assessment

How should we assess risk and how can we use the process to assist in evaluation audit findings?

Break

Current hot topics in GLP

Explore the current issues in Industry and trends /types of Regulatory inspection findings

GLP Clinic

An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance.

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.

7 Points

Learn