Sterility testing of pharmaceutical finished products, medical device testing, and other clinical research samples are required to be tested for sterility during the sterilization validation process as well for routine quality control. Sterility testing is employed as a measure of the adequacy of sterilization parameters for finished product manufacturing. An understanding of sterility testing is beneficial in terms of designing a validation process, test methods, and overall criteria for sterile pharmaceutical finished products and medical devices. The need to provide adequate and reliable sterility test data is an important tool to detect and rectify quality control issue. Sterility testing is a very tedious and artful process that must be performed by trained and qualified laboratory personnel. The investigation of sterility test failures is a process that requires attention to environmental data as well as many other factors including training and sample difficulty. Quality Assurance is also an important part to maintain compliance and assist in sterility related batch release and issues that arise during testing.  Recently, the USP has committed to harmonization of this general chapter with its international counterpart’s; European Pharmacopeia (EP) and the Japanese Pharmacopeia (JP).  This new harmonization effort along with an overview of the most effective and compliant testing parameters will be discussed in this training.

Course Objectives:

• To identify which facilities and personnel that are impacted by an USP <71>
• Become familiar with the different types of sterility testing and controlled environments used to support testing
• Identify and become familiar with the new harmonization efforts and impact
• Implementing and maintaining a Quality environment (QA recommendations)
• Familiarization with validation activities necessary for qualifications of testing parameters and equipment used for testing
• Supportive testing requirements for media used and organisms used in testing and detection
• Types of products affected by USP <71>

Course Outline:

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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

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