8 hrs VILT, 3 hrs self-paced
Facilities and Equipment 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.
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.
On completion of this course delegates will know and understand:
The high-level principles of design of drug product manufacturing facilities, including utilities
The Concept of Process Validation
Current Regulatory Expectations
How to Gain Process Understanding (FDA Stage 1)
Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1)
Process Validation/Process Performance Qualification (PV/PPQ) (FDA Stage 2.2)
Continued/Ongoing Process Verification (FDA Stage 3)
Tools That Enable Effective and Efficient Validation
This course is ideal for technical, engineering, and managerial personnel responsible for facility/utility/equipment qualification and process validation, quality unit staff, and regulators.
Course tutors will be selected from the following: