This module provides the students with a broad understanding of the newly
emerging tools, standards and approaches by pharmaceutical companies and
regulators to ensure the safety, efficacy, quality and performance of medicinal
products, with emphasis on validation and related activties in the
Manufacturing/Commercial phase of the lifecycle. It brings together the component
parts of the ICH Q10 enablers QRM and Knowledge Management
Indicative syllabus covered in the module and / or in its discrete elements;
· Emerging Regulations in the area of Regulatory Science
· The Pharmaceututical Lifecycle, and the role of Validation in supporting it.
· Knowledge Management,
o Tools
o Framework
o Application
· Risk based decission making
· The inter-relationship between Risk and Knowledge, and QRM and KM
· Quality Metrics for Validation
o Lagging Metrices
o Leading Metrices
Webinars, Lectures, Videos, Group work, Networking
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |