The module is essential for all candidates who expect to take the QP Viva. It forms a valuable contribution to Continuing Professional Development for those QPs who qualified some years ago.
Other managers and supervisors from within pharmaceutical manufacturing will benefit from attending this course as they will gain a thorough understanding of the relationship of the QP with their own role.
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.
Learning Outcomes
By the end of the course you will learn and understand:
The legal responsibilities of a QP within the EU
The Code of Practice for the QP
An overview of the regulatory framework pharmaceuticals in the EU/EEA
The certification process for a medicinal product according to Annex 16 and other applicable guidelines
The QP and the Pharmaceutical Quality System
How to deal with typical product problem situations
The interpersonal skills associated with the role of the Qualified Person within the pharmaceutical industry
