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
Please note timings are subject to alteration
|9.10||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.
|10.00||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||Workshop on Data Integrity
To explore the practical issues of assuring data integrity.
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|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
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.
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
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