Qualification and validation: two words that cover a lot of ground, particularly for isolator fill/finish lines. Risk analysis, documentation, cycle development, factory/site acceptance testing, and the list goes on. These processes can seem overwhelming, but it does not need to be. With an understanding of requirements and up-front planning, these critical stages can run smoothly, ensuring your isolated fill line is ready for production in record time.
This webinar will provide background on the regulatory landscape, insight into when qualification should start on an isolator project, the steps necessary for planning/preparation ahead of machine manufacture and what it takes for execution of the essential steps required for an isolated line prior to operation.
Our experts Andrey Yermakovich, Dr. Laura Moody and Matthias Angelmaier will lead our free event, "Minimum requirements for successful qualification and validation of isolators" on Wednesday, April 14, 2021. Join them to learn more about qualification and validation of isolators, plus have your questions answered during the interactive Q&A session.
This event will take about 30 minutes plus interactive Q&A session.