Event
Course Description:
This course includes facts and fundamentals of Sterile drug products. It also covers the framework of global regulations and guidelines of sterile products. Participants will be engaged in discussions, activities and/or case studies to reinforce key learning.
By taking this course, you will learn about:
- Explain the basics of sterile products and regulatory/scientific concepts, drivers of sterile products manufacturing and discuss key elements
- Describe the best methods/ practices related to various elements of sterile manufacturing
- Describe key processes and performance attributes that have influence on the outcome of the sterile processes and capability elements to be integrated into the process
- Explain the key concepts of sterile products manufacturing and an overview of global regulatory framework for sterile products manufacturing
- Describe the requirements of various regulatory authorities specific to sterile products manufacturing and key differences among these regulations
- Demonstrate knowledge of the underlying concepts of contamination controls and the key elements of the life cycle maintenance for sterility assurance via case study, Q&As, and knowledge checks
Who should participate:
- Microbiologists
- Auditors
- Manufacturing companies
- RnD injectables companies
- DQA
- QA and QC controls
- Engineering
- Biopharma / Vaccine industry
- Aseptic control
- People working in sterile conditions