Current Trends in Sterile Manufacture for Pharma and Biotech Industry
Mumbai, India - This program addresses latest trends in European industry standards, and inspection agency demands, in regulatory and quality arenas of sterile manufacture.
This program addresses latest trends in European industry standards, and inspection agency demands, in regulatory and quality arenas of sterile manufacture. The program has been conceptualized and will be anchored by well-known experts from Europe in the field of sterile manufacture. It also address concerns of the Indian industry with respect to microbiological details, environmental issues and how to solve common and not-so-common problems related to sterile manufacture. The program has incorporated special sessions on CMC, its application and importance to Indian industry.
Objectives
- Current QA concepts related to Sterile Manufacture.
- Latest updates on Microbiology Concepts and Techniques.
- Applying Risk Management Strategies to Aseptic Operations.
- Designing a good GLP Compliant Microbiological Laboratory.
- Key aspects of an Aseptic Processing Manufacturing facility including knowledge of Biotech Processing.
- Cleanroom standards, requirements and regulation.
- Microbiological Validation.
- Containment of Penicillins and Cephalosporins.
- Environmental Monitoring.
- Proper gowning requirements for Aseptic Areas.
- Sterile Engineering in Biotech Manufacturing
- CIP and its Validation
- Investigation of Microbiological Failures.
For more information, please email [email protected]
