Event
Course Description:
This course talks about quality room framework, application of QRM in sterile manufacturing and QRM model for sterile manufacturing. Participants will be engaged in discussions, activities and/or case studies to reinforce key learning.
By taking this course, you will learn about:
- Explain Key elements of quality control of sterile products and principles/ applications of quality risk management in sterile manufacturing
- Describe Critical attributes tested in sterile products across the life cycle and various approaches of QRM in sterile products manufacturing
- Demonstrate Method validation and analysis qualification requirements and effective use of QRM for determining control strategies via practical course activities.
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