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About This Webinar

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.

When: Wednesday, April 14, 2021 · 05:00:00 PM · Berlin
Duration: 1 hour 30 minutes
Language: English
Who can attend? Anyone with the event link can attend
Dial-in available? (listen only): No
Featured Presenters
Webinar hosting presenter
Global Prdouct Manager
Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as
well as a master’s degree in business development. He joined Syntegon Technology GmbH (former Bosch Packaging Technology) in 2009.
During his first 3 years, he was a project manager for handling complex customer projects.
Since 2012, he is the globally responsible product manager for barrier systems, isolator and process
technology. His expertise includes process engineering, sterilization, bio-decontamination,
aseptic and high-potent Isolator applications, glove testing systems as well as topics related
to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA.
Webinar hosting presenter
Product Manager
Laura Moody earned her Ph.D. in cellular and molecular biology at the University of Wisconsin – Madison. Her postdoctoral training focused on the identification of FDA-approved drugs for the treatment of a rare, genetic neurodegenerative disorder. Laura worked for three years as the technical lead for the cell-based drug screening, manufacturing and custom cell-based services group at Thermo Fisher Scientific, specializing in large-scale cell-based initiatives. Since July 2018, she has been the North American product manager at Syntegon Pharma Technology, with a focus on pharmaceutical liquid packaging for fill/finish applications. She belongs to several industry organizations including ISPE and PDA, where she has acted as presenter, moderator and trainer at domestic and international events.
Webinar hosting presenter
Validation Supervisor
• With Syntegon from Dec, 2002
• Responsible for North American market commissioning and qualification activities
• Strong electromechanical / technical background
• Education background is in Automated Machinery Systems/Packaging at HTC in Minneapolis
• Consulting pharma customers: qualification project management, solution development and implementation
• 2 years in Crailsheim, Germany to help increase collaboration between US and German sites
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