Online Course November 9th 2023 at 6:00am – 7:30am EDT
With the publication of the new Annex 1, pre-use post sterilization integrity testing (PUPSIT) of the sterile filter in front of a filling system has been once again emphasized. However, different to previous versions, the regulators added a sentence that it may not be always possible to perform such test and risk assessment tools shall be utilized to find an alternative. PDA and BioPhorum’s task forces on PUPSIT have created a wealth of scientific data; incl. masking studies, data mining, points to consider implementing the test and risk assessment from filter production to end-use. This webinar discusses the pros and cons of PUPSIT as well as the task force findings.
Your Trainer
Maik W. Jornitz, Founder and Principal Consultant of BioProcess Resources
Maik W. Jornitz, Founder and Principal Consultant of BioProcess Resources, is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration and filter integrity testing. He has published multiple books, book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.
In his previous roles, he was the CEO of G-CON for 10 years, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
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