Pharmaceutical Quality Systems
Ensuring Pharmaceutical Quality through PQS Implementation
The purpose of a Pharmaceutical Quality System (PQS) is to ensure that medicinal products are fit for use, comply with regulatory requirements and do not place patients at risk due to inadequate safety, quality or efficacy.
This course provides a comprehensive overview of the requirements of a PQS through interactive scenarios and exercises, providing practical examples of how the PQS can be implemented in the real world, and the roles and responsibilities within the organisation with respect to the PQS.
Key Topics
The course covers the following topics:
- Philosophy of Quality Management
- Introduction to PQS
- Quality Risk Management
- Training
- Calibration and Maintenance
- Validation and qualification
- Issue, deviation, complaint and recall management
- Audits and self-inspection
- Change management
- Product quality reviews
- Management of outsourcing
- Management review
- Principles of a “Quality Culture”
Learning Outcomes
By the end of this course you will understand:
Who should attend?
This training is of benefit to anyone working in quality (compliance or quality system) or operational roles, providing the latest updates required for effective Continuing Professional Development (CPD).
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