USP <71> Sterility Testing: New Harmonization with International Compendia and Overview 2016

Topics

• Classifications and examples of organisms and media used for testing
• Types and examples of controlled environments and the techniques used in sterility testing per USP 71
• QA program for controlled environments and sterility testing performed/evaluations
• Personnel trainings and evaluation recommendations
• Common errors and microbial contamination found in the sterility samples
• Areas for validation activities and applicable regulations
• Harmonization of USP 71 with other USP chapters and international regulatory bodies
• List of products and testing requirements per USP 71

Who should Attend

Attendees from:

• Quality Assurance personnel and support staff in the biotechnology/pharmaceutical technology industries
• Biotechnology manufacturing personnel and support staff in the biotechnology/pharmaceutical technology industries
• Finished product and medical device testing and manufacturing facilities
• Quality Control laboratory personnel and support staff in the biotechnology/pharmaceutical technology industries
• Pharmaceutical and general contract laboratory companies/entities with cleanroom facilities
• Environmental Monitoring Program manager and support staff in the biotechnology/pharmaceutical technology industries
• General laboratory personnel and staff who do routine work in cleanroom or control testing environment