This module provides the students with a comprehensive understanding of the
purpose and scope of Equipment Qualification and the regulatory frame work
around Validation. In addition it introduces the student to the Quality Risk
Management
The topics covered in the module include: Pharmaceutical regulation with emphasis
on Facility, Utility and Equipment Qualification , GEP, engineering drawing and
Quality Risk Management,
· History and evolution of Validation, with emphasis on Equipment Qualification
· General Equipment qualification Regulatory Requirements
· GMP, including training of personnel involved in Equipment Qualification
activities.
· Fundamental engineering terminology, documentation, drawings, symbols, GEP –
e.g. P&IDs, critical instrument lists etc.
· Risk-based approach to Equipment Qualification, System Classification, Defining
Systems and system boundaries, Impact assessments
· Planning and programming of Validation exercises, Validation Policy, Validation
Master
· Plans, Validation plans and schedules, with emphasis on Equipment Qualification
· USRs and Life-style approach
· Prerequisites for Equipment Qualification, Calibration and Plant Handover
· Equipment Qualification Procedure and Terminology
· Equipment Qualification Documentation
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Case-studies, webinars, live lectures, pre-recorded videos
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |