Role and Professional Duties - QP Module
Reading Scientific Service Limited (RSSL)
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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
Prerequisites
There are no prerequisites for this course. For more information, please click find out more.
Additional information
Teaching method: online/classroom
Teaching provider
Useful information
Country: UK
Teaching method: Class/lab
Duration: 2 days
Cost: £1640.00 Plus VAT
Language: English