Event
Course Description:
This course includes an overview of the sterilization process, key definitions and types of sterilization. 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 components of the cleanroom in sterile manufacturing and considerations in design of the cleanrooms
- Describe Various operational/ monitoring controls to maintain the desired state in cleanrooms for sterile manufacturing across the life cycle
- Demonstrate proficient knowledge of the roles of stakeholders in the design, operation and monitoring of cleanrooms in alignment with regulatory expectations via case study, Q&As, and knowledge checks.
- Explain the basics of sterile products and regulatory/scientific concepts, drivers of sterile products manufacturing and discuss key elements
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