1- Introduction to Validation
2- Validation as an essential part of GMP
Overview
Concepts
Definitions
3- Validation Master plan VMP
When it is required
Responsibility
Contents of VMP
Points to be consider in VMP
Qualification /Validation Protocols Format
4- Type of validation
Retrospective Validation
Concurrent Validation
Prospective Validation
5- Validation Supporting Systems
Quality assurance
Quality Control
Engineering
6- Steps of New Project Validation
7- Example and case studies
Sterilization validation
Test method Validation
Cleaning validation
12(hours)