Introduction to this course: 

Discover aseptic processing and terminal sterilization for sterile drug products. Learn the essential methods, regulations, and best practices to ensure sterility in pharmaceutical manufacturing. This course covers terminal sterilization techniques, aseptic processing steps, regulatory frameworks, cleanroom standards, and advanced technologies like isolators and RABS.

Who should attend: 

This course is intended for manufacturing professionals, quality assurance and quality control personnel, regulatory affairs personnel, microbiologists, production managers, and anyone involved in sterile drug production and assurance. Those interested in aseptic processing, terminal sterilization, and regulatory compliance can also benefit.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Recall the fundamental principles and techniques of aseptic processing and terminal sterilization in pharmaceutical manufacturing.

• Apply industry regulations and guidelines, including FDA CGMP and EU GMP Annex 1, to ensure compliance and maintain sterility.

• Analyze different sterilization methods to determine the most suitable approach for various drug products.

What will I gain: 

Participants will gain in-depth knowledge and regulatory insight into aseptic processing and terminal sterilization techniques.

Prerequisites: 

Prerequisites for this course include a basic understanding of fundamental concepts in drug production and quality control. 

Additional information: 

Course duration: 00:15:40

Course code/version (effective date): L-1010/v1.0 (28/02/2024)