Management Review

The training

A half-day training course on the practical tools and background for implementing PQR. The responsibility for managing the Pharmaceutical Quality System (PQS or also known as QMS) lies with the management. They set the vision and direction of the organisation and provide the necessary resources to foster a culture of quality. Since the quality system should be parallel to the business needs, the Management Review provides an excellent opportunity for management to review the QMS. The task of ensuring that the QMS is reviewed annually for effectiveness lies in the hands of the QA department. The achieved targets are reviewed and new targets have to be set. The progress of the multi-year plan is also reviewed during these sessions. All this within the framework of continuous improvement of the processes, products and the quality system itself. The Product Quality Review (PQR) serves a similar purpose, assessing, among other things, the consistency and adequacy of current processes. It also looks at how adequate the current specifications for starting materials and finished products are. Together, these two reviews form the basis for identifying areas for improvement of process and product. To make the reviews as efficient as possible, a good understanding and organisation is required.

Target group:

This training is intended for employees in the pharmaceutical industry, such as QA/QC Managers and Officers, QPs and Management.

Results:

• Relevant results
• An engaged management and better understanding of your own products
• Continuous improvement of your processes

Contents

• What and why Management Review?
• Legal framework
• Quality metrics
• Example Management Review