About This Course
Quality Systems are critical to ensuring an operation meets cGMP expectations and they provide the Quality Unit the confidence that the site or company is operating within the regulatory framework. Regulatory Inspections from the US FDA frequently list findings against the quality system and raise Warning Letters for the same.
This highly interactive course, is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.
Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.
Key Learning Objectives
On completion of this quality system training course delegates will know and understand:
- What is a Quality System and what is in a Quality System
- How the Quality System is applied throughout the lifecycle of a drug substance and drug product
- How to demonstrate to inspectors and management that the Quality System is effective
- The impact of culture on the Quality System
- Principles and expectations of the Quality System
- Product lifecycle
- Quality System elements
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, 9, 10 and the PQS
- Senior management and the Quality System
- People – selection and development
- Documentation – data integrity
- Change management
- Deviation management
- Audits and self-inspections
- Complaints and recalls
- Annual product quality reviews (PQRs) and management reviews
- Continuous improvement and quality metrics
Who Should Attend
Quality Unit Professionals and Pharmaceutical Technical Professionals
- These courses are suitable for professionals working at drug substance and product manufacturing sites and those whose role requires them to understand site level or company level quality systems.
- Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.
Course tutors will be selected from the following:
- Rachel Carmichael
- Christian Sonntag
- Peter Calcott
- Joanna Gallant
- Matt Peplowski