Vastek Group

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

Pharmaceutical Drugs and Biologics

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