This module introduces the student to fundamental aspects of process validation, validation planning and statistical methods for validation. It is designed to introduce the student to the Pharmaceutical Manufacturing environment.
The topics covered in the module include: Pharmaceutical regulation with emphasis on Validation and GMP, Planning and managing Validation activities, Pharmaceutical Statistics
Indicative syllabus covered in the module and / or in its discrete elements;
History and evolution of Validation, with emphasis on Process Validation
General Process Validation Regulatory Requirements and compliance
Overview of all validation activities and the validation framework
GMP including training of personnel involved in Process Validation Activities
Planning and programming of Validation Exercises, Validation Policy, Validation Master Plans, Validation plans and schedules, with emphasis on Process Validation
Project Management and Project Management Software
The Validation Master Plan
Statistics and Sampling
Prerequisites for Process Validation
Process Validation Procedure and Terminology
Process Validation Documentation
Deviations, non- conformances and change control with regard to Process Validation
Process Validation
Indicative syllabus covered in the module and / or in its discrete elements;History and evolution of Validation, with emphasis on Process ValidationGeneral Process Validation Regulatory Requirements and complianceOverview of all validation activities and the validation frameworkGMP including training of personnel involved in Process Validation ActivitiesPlanning and programming of Validation Exercises, Validation Policy, Validation Master Plans, Validation plans and schedules, with emphasis on Process ValidationProject Management and Project Management SoftwareThe Validation Master PlanStatistics and SamplingPrerequisites for Process ValidationProcess Validation Procedure and TerminologyProcess Validation DocumentationDeviations, non- conformances and change control with regard to Process Validation
Lectures, case studies, workshops , webinars
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |