The Good Laboratory Practice (GLP) regulations are designed to ensure the quality and integrity of non-clinical laboratory studies. Within those requirements are defined roles and responsibilities including the Study Director (SD).
This interactive and engaging course will provide you with an understanding of what is expected from individuals acting as Study Directors in GLP studies. Upon completion of this course, you will be able to identify the specific responsibilities of an SD and understand the importance of having a single point of control for a study
This course can be booked on an individual or group basis. If you are interested in training for you or your organisation, please contact training@towermains.com.
✔ Application of the Principles of GLP as an SD
✔ Understanding the role and responsibilities of an SD
✔ Practical examples of SD responsibilities
This course would be beneficial for individuals who have a basic understanding of GLP and:
✔ Are starting in or are hoping to move into the role of SD
✔ Have worked in other areas and want to understand if an SD role is right for them
✔ Require reinforcement of SD responsibilities
1 day
This course is broken down over four topics.
Topic 1:
- When does GLP apply
- Roles & Responsibilities – focused on Study Director
Topic 2:
- Study Conduct
- Protocols / study plans
- Amendments and Deviations
Topic 3:
- Test Items
- Data Integrity
- Reporting
Topic 4:
- Quality Assurance
- Archiving
- Question & Answer session
This course consists of a mixture of presentations and interactive group exercises.
An electronic certificate of attendance will be issued to each delegate.
If you are interested in booking a future course, please contact Erin Bell to register your interest.
Testimonials
“Thank you for such fantastic training. I learned so much and was really inspired by both teachers’ experience and knowledge. They both brought such great energy and a very positive attitude.”
“Excellent presenter. Clearly very experienced and shared his experiences very well.”
“The examples and stories were very interesting and made this training different from other GCP refresher trainings that just stick to reviewing GCP sections one by one.”
“Really lovely style, laidback, friendly, informative. Great tutor”
“Extremely knowledgeable”
