Watch You have a Sterility Failure or Bioburden Excursion Event Streaming Online

This Sterility or Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation. Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint. reas Covered in the Seminar: * Is this result really a failure that needs to be investigated? * What items are important to investigate during sterilization process validation? * If a failure occurs during sterilization process validation what actions can you take? * The lab says the routine process BI is positive, what now? * My dose audit did not pass, what does that mean? * The periodic bioburden testing exceeded the established alert limit, what actions should be taken? * What do you do if the bioburden action limit is exceeded? * How to determine if the bioburden excursion has an impact to sterilization. Who will Benefit: This webinar will provide valuable information to all companies that produce sterile medical devices. * QA personnel * Validation specialists * Manufacturing personnel involved in validations * R&D specialists Instructor Profile: Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance. more