COURSE INFORMATION
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.
IS THIS COURSE FOR YOU?
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.
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TUTORS
Tutors will be comprised of (click the photos for biographies):
VANESSA GRANT
-, -
TIM STILES
Consultant, Qualogy Ltd
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PROGRAMME
Please note timings may be subject to alteration.
DAY 1
09:00
REGISTRATION, WELCOME AND INTRODUCTION
09:20
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.
09:50
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.
10:30
BREAK
10:45
WORKSHOP 1
Workshop 1 Roles and responsibilities
11:15
INFLUENCE OF SPONSORS
The published OECD Position Paper No. 21 regarding Possible Influence of
Sponsors on conclusions of GLP Studies is reviewed and discussed.
11:45
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.
12:30
LUNCH
13:15
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
13:45
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
14:15
WORKSHOP 2
Workshop 2 Change control
14:30
RISK ASSESSMENT
How should we assess risk and how can we use the process to assist in evaluation
audit findings?
15:00
BREAK
15:15
CURRENT HOT TOPICS IN GLP
Explore the current issues in Industry and trends /types of Regulatory
inspection findings
15:50
GLP CLINIC
An opportunity to discuss any other issues regarding understanding and
maintaining GLP Compliance.
16:30
CLOSE OF COURSE
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EXTRA INFORMATION
COURSE MATERIAL
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.
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 Access to an online
course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
CPD POINTS
7 Points
DEVELOPMENT LEVEL
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