Scope
All pharmaceutical companies must have a pharmaceutical quality system to ensure that safe, quality products are delivered to patients and to satisfy the requirements of the regulatory authorities.
- How do you know your quality system is fit for purpose?
- How does your quality system compare to other companies?
- How can you make sure you focus on what is important?
- What is the role of management and staff in ensuring the quality system is effective?
This interactive one-day course, which combines tutorials and exercises, enables participants to answer these questions and to develop an action plan to drive improvement.
Suitability
This course is suitable for managers at all levels who wish to understand the requirements for a PQS; managers who are responsible for developing or improving their PQS; and managers who are involved in quality planning. It is also ideal for both practising QPs and middle managers in Production or QA wishing to top up their knowledge of Pharmaceutical Quality Systems.
By the end of the course you will:
- Understand the requirements for the PQS
- Assess the scope and status of the PQS that is operated in your company
- Understand the responsibilities for ensuring the PQS is effective and improved where necessary
- Understand the approaches to managing PQS improvement
- Understand the importance of culture in an effective PQS
