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USP<71> Sterility Tests represents the "Gold Standard" for sterility testing. Together with both the European Pharmacopeia (EP 2.6.1 Sterility) and the Japanese Pharmacopeia (JP 4.06 Sterility Test), they represent a 90+% harmonised test method that is utilised to determine the sterility of a product.
A variety of issues with USP <71> make it a difficult test to understand, develop and follow within one’s laboratory. Everything from Growth Promotion testing of the media to assuring no inhibition/enhancement (I/E) of the product to be tested requires the knowledge and assurance that the test is being completed as required. In addition, the number of units necessary for testing, the total volume required for the test and assurance that the media is providing accurate results all become important aspects of assuring the test is performed properly and the final result meet those specifications. Finally, correct interpretation of the results and the proper procedures to use should a failure occur require a thorough knowledge of USP <71>. Any failure of a Sterility Test will also cause one to potentially review all of the elements within the media fills or terminal sterilisation validation that were involved in developing the process that would provide the final, sterile end product.
A failure of a Sterility Test (whether an accurate result or not), will result in an investigation to determine the “root cause” of the failure. Even if that “root cause” is determined, management will quite often determine, in the current regulatory environment, to scrap the product, rather than second guess the regulatory agencies that will periodically audit them. With sterility testing being an exacting procedure, and assurance of asepsis essential, it is important that personnel be properly trained and qualified.
The test for sterility is performed under aseptic conditions within an ISO Class 5 hood or within an ISO Class 5 Isolator. Precautions are required to assure that neither microorganisms from the individual testing or the environment contaminate the product being tested. The working condition of the area in which the test is performed should be monitored regularly by appropriate sampling of the working area and by using appropriate aseptic methods to provide control. Each of these areas will be discussed in detail.
The objective of this webinar is to obtain an enhanced understanding of USP <71> Sterility Tests, its inherent method, limitations, sampling quantities and volumes to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result, regardless of whether it represents a pass or a failure. Review of Case Studies/Warning Letters will also be reviewed to further explain this document.
-Methods of sterility testing.
-Review of the appropriate media to use for sterility testing.
-Determination of the quantity of each article for testing and why.
-Review of number of items for each medium and why.
-How to select the appropriate technique for testing.
-Use of diluents with sterility testing.
-Interpretation of the results – regardless of a pass or failure.
-Review of pertinent Warning Letters.
Who should attend?
The following individuals or disciplines will benefit from attending this Webinar:
•Quality Assurance personnel
•Quality Control personnel
•Research & Development
•Regulatory Affairs Professionals
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.