Approved training courses
A Qualified Person (QP) must certify that each batch of medicinal product (for human or veterinary use) complies with its Marketing Authorisation or Clinical Trial Application, GMP and certain other requirements. Their conduct overall must comply with the Code of Practice for QPs.
This course provides a comprehensive overview of the requirements of the UK Study Guide and, by using interactive questions and scenarios, shows how the Qualified Person can comply with the legal and operational requirements of the role.
The course includes the following topics and reinforced using group exercises:
Day 1
- Annex 16 - Knowledge check
- Overview - role of QP
- PQS & QP Oversight
- MIA / MA / equivalent
- Product Development
- QP in Production
- Batch Certification
- Unexpected Deviations
Day 2
- Storage and Distribution
- Complaints and Recall
- RSC Presentation - QP Application Process
- Regulatory Inspections
- Clinical Trials
- Contract QP
- Impact of Brexit
On request from training provider
Class/lab
2 day
£1390.00 GBP (plus VAT)
Find an approved training course
Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.
Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.
