The course is aimed at providing a reminder and refresh insight of the key GLP requirements and responsibilities and also to look at recent hot topics and trends. Specific areas covered include Data Integrity, Risk Assessment, the new OECD guidance on Sponsor Influence, the OECD guidance on Test items. The programme also includes a GLP clinic where delegates can identify any relevant topics for discussion.
The course is aimed at Study Directors, Principal Investigators, Test Facility Management and QA.
Tutors will be comprised from the list below:
Regulatory Compliance Consultant, Qualogy Ltd
Associate Director, AstraZeneca
"Vanessa presented her story really clear and responded nice and directly on questions. Especially the examples from her own experience helped a lot to clarify the information received / the questions asked. The different exercises on Data Integrity (though not always directly clear from the start) were a really nice variety with listening to the story. If possible, more exercises would help to maintain concentration. Nevertheless, it was really nice to have Vanessa as a tutor."
"It is very informative and with good discussion."
"Topics of OECD nr 19 were described and discussed. Especially the different examples were very helpful."
|Welcome and Introduction|
|9.15||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 as well as possible impact of Brexit.
|9.45||Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA
A reminder of the role of the Study Director in the management and control of a study, as defined by GLP, and Management’s roles are explored.
With the publication of the MHRA Guidance document on Data Integrity has the challenge changed?
The responsibilities of Study Director, Test Facility Management and study staff in ensuring the integrity of the GLP study data.
Including exploring the practical issues of assuring data integrity.
|11.45||Influence of Sponsors
The recently published OECD Position Paper Number 21 regarding Possibly Influence of Sponsors on Conclusions of GLP Studies is reviewed and discussed..
How should we assess risk and how can we use the process to assist in evaluation audit findings.
|14.15||Test Item Requirements
What are the new requirements from OECD No.19 and what are the expectations on the Study Director /Principal Investigator and Test Facility Management.
A chance to discuss your own issues.
|16.00||Current Hot Topics in GLP
Explore the current issues in Industry and trends /types of Regulatory inspection findings
|16.30||Close of day|
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.
You will need a stable internet connection, a microphone and a webcam.
A Practical Guide for the Good Laboratory Practice Study Director
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Guide to the Role and Responsibilities of GLP Management
Management of the Training and Competency of Personnel in GxP and Research Environments
P04 Quality Assurance for Good Laboratory Practice
P16 Good Laboratory Practice Refresher
P32 Process Mapping and SOP Writing
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING