This training focuses on understanding of the
requirements of validation for both small molecule
(pharmaceuticals) and Biologic products. This
training reflect the current requirements and
guidance’s published by the European Medicines
Agency, FDA and International Conference on
Harmonization
.
Topics to be discussed include:
- Introduction to Process Validation
- Process Validation Definition
- Types of Process Validation – Prospective, Retrospective, Concurrent
- Facility Validation
- Cleaning Validation
- Processing Equipment Validation
- Sterilization Validation
- Packaging Validation
- Basics of Statistical Tools
- Process Validation Compliance
- Supplier Process Validation
- Laboratory Equipment Validation and Qualification Process
- Equipment Categories – Group A, Group B, Group