Approved training courses

Course description

The Roles and Duties course is mapped to the UK Study guide. The learning outcomes are:

- Regulations and guidelines essential for the Qualified Person, including
- Good Manufacturing and Distribution Practice (GMDP)
- UK and EU/EEA legislation / guidelines
- Global and regional legislation / guidelines e.g. PIC/s, ICH, FDA

- The specific requirements related to the position of the GMP Qualified Person as defined in UK, EU/EEA legislation, including:
- Annex 16, Annex 21 and other specific elements
- UK QP Study Guide and Code of Conduct
- The role of the QP in regulatory inspections and their relationship with holders of Manufacturing and Marketing Authorisations

- The obligations of the Qualified Person in the oversight of the Supply Chain and Pharmaceutical Quality Systems
- With practical advice on how to appropriately delegate whilst maintaining oversight

- Key interpersonal skills for the QP


QPQuandary Ltd use a mixture of presentations, exercises (scenarios), and workshops to incorporate technical knowledge, leadership, and interpersonal skills to help delegates meet their aim of attaining the position of Qualified Person (QP).

Training is delivered by QPs and Subject Matter Experts from the Pharmaceutical Industry. The course is interactive, with materials, assignments and assessments provided through a learning portal. Delegates must complete pre-course work, end of day exercises and post coursework.

A certificate is issued on completion of the course and assignments.

Pre-requisites

The course is suitable for delegates working towards the role of the Qualified Person and for existing QPs and Quality Professionals involved in manufacturing medicines, who wish to maintain Continuing Professional Development.

Additional info

The course is instructor led, with training delivered at the Maidstone Innovation Centre and online.

Training provider

QPQuandary Ltd

Email

info@qpquandary.com

Tel

01622477781