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International QA Conference 2023, Belfast
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About us
Good Laboratory Practice Refresher and Hot Topics REMOTE LEARNING
REMOTE LEARNING - this course will be delivered to you live online from the UK.
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
Course Information
The course is aimed at providing a reminder and refresh of the key GLP requirements and responsibilities including Data Integrity and also to look at recent hot topics and trends including feedback from MHRA Inspections. Specific areas covered include Risk Assessment and the OECD guidance on Sponsor Influence and OECD Advisory on QA. The programme also includes a GLP clinic where any issues raised by the delegates regarding understanding and maintaining GLP Compliance can be discussed.
The course is aimed at Study Directors, Principal Investigators, Test Facility Management and QA.
Course Tutors
Tutors will be comprised from the list below:
Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd
Vanessa Grant
Recent Feedback
"Tim's presentation was comprehensive and covered a wide range of topics relevant to my role as a SD. Tim gave valuable information when replying to questions during the presentation."
"Good and lively presentations, very nice prepared slides and able to provide feedback on any question raised."
"Tim presented the story in a way that was encouraging to deeper thoughts about the topic and to develop a wider discussion. It was really nice to have him as a tutor."
CPD Points
7 Points
Course Programme
Please note this course will run in UK timezone.
| 9.00 | Registration |
| 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. |
| 10.30 | Break |
| 11.00 | Data Integrity 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.. |
| 12.45 | Lunch |
| 13.45 | Risk Assessment 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. |
| 14.35 | GLP Clinic A chance to discuss your own issues. |
| 15.15 | Break |
| 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 |
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.
Recommended Products
Booklets
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
Courses
P04 Quality Assurance for Good Laboratory Practice
P32 Process Mapping and SOP Writing
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
eLearning Products
Advanced Good Laboratory Practice (GLP) elearning
Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Clinical Practice (GCP) elearning
