1- Introduction to Process/Method validation
2- Essential of Process/Method Validation
3- Regulatory Requirements of Process Validation
4- Harmonization GMP & Validation
5- Technology Transfer and Related requirements
6- Pre-request for Process Validation:
Developed method
Transferred method
Compendial method
7- Risk Based Approach for Process Validation
8- Group Discussion (Process Flow Chart and Control Points)
9- Manufacturing Process and Controls
10- Project validation Master Plan
11- Processes Validation Master Plan
12- Product development and Validation life cycle
13- Developing the Process Validation Protocol
14- Key Steps in the Validation Life Cycle of a New Process
15- Pharmaceutical Ingredients
16- Blend uniformity
17- Solid Dosage Form
18- Biotechnology Process
18(hours)