Course Overview
Recent changes to the EU Guide to GMP emphasise the importance of Senior Management involvement and commitment in the design, implementation, maintenance and monitoring of the Pharmaceutical Quality System (PQS). This is the first time that European guidance explicitly articulates the wide-ranging role of Senior Management beyond the Heads of QA and Production and the Qualified Person. It is therefore likely to be a key area of focus during regulatory inspection.
So how does a Senior Manager actually demonstrate their commitment and support for the Pharmaceutical Quality System?
This interactive one day course, which combines tutorials and exercises, enables Senior Managers to discover what their responsibilities are, how they can discharge them effectively, and develop an action plan to facilitate delivery in their organisations.
Suitability
This course is suitable for those Senior Managers who wish to gain a strong appreciation of a PQS and the practical steps they can take to ensure they have a well-defined and effective PQS in their organisation. In addition, it is ideal for both practising QPs and middle managers in Production or QA wishing to top up their knowledge of Pharmaceutical Quality Systems. This course can also be run as an in-house course.
Learning Outcomes
The course is highly interactive with comments, personal anecdotes and questions encouraged throughout. By the end of the course you will understand:
Recent changes to the EU Guide to GMP emphasise the importance of Senior Management involvement and commitment in the design, implementation, maintenance and monitoring of the Pharmaceutical Quality System (PQS). This is the first time that European guidance explicitly articulates the wide-ranging role of Senior Management beyond the Heads of QA and Production and the Qualified Person. It is therefore likely to be a key area of focus during regulatory inspection.
So how does a Senior Manager actually demonstrate their commitment and support for the Pharmaceutical Quality System?
This interactive one day course, which combines tutorials and exercises, enables Senior Managers to discover what their responsibilities are, how they can discharge them effectively, and develop an action plan to facilitate delivery in their organisations.
Suitability
This course is suitable for those Senior Managers who wish to gain a strong appreciation of a PQS and the practical steps they can take to ensure they have a well-defined and effective PQS in their organisation. In addition, it is ideal for both practising QPs and middle managers in Production or QA wishing to top up their knowledge of Pharmaceutical Quality Systems. This course can also be run as an in-house course.
Learning Outcomes
The course is highly interactive with comments, personal anecdotes and questions encouraged throughout. By the end of the course you will understand:
- The relationship between ICH Q10 (Pharmaceutical Quality Systems) and the EU Guide for GMP (Volume 4)
- The scope of the PQS that is operated in your company
- Senior Management responsibilities for a PQS that is operated in your company
- The importance of culture in an effective PQS
- The importance of Key Performance Indicators (KPIs) and management reviews
- Deming cycle and continuous improvement of the PQS
