Pharmaceutical Drugs and Biologics

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