Process Validation of Sterilizing Grade Filters

The regulatory authorities have very specific requirements to process validate a sterilizing grade filter. Anything less than meeting these requirements will cause regulatory scrutiny. The webinar will discuss the past qualification efforts, which have not satisfied the regulators to today’s process validation needs and activities. Every validation need and expectation will be discussed in detail and what are the required actions. A must to comply with the regulatory authorities and critical determination whether the filter functions as anticipated.

60 minute Online Course October 16th 2023 at 15:30pm IST / 6:00am EDT / 11:00am BST / 12:00pm CEST

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.

Learning Objectives:

  • Regulatory requirements

  • Difference between qualification and validation

  • Product bacteria challenge testing

  • Leachable testing

  • Other test requirements

  • Step by step activities

Who will benefit:

Manufacturing
• Operators/Technicians/End Users
• Laboratory/Process Supervisors/Managers

Regulatory
• Validation/QA
• Process Development

Course Schedule:

From 6.00am - 7:30am EDT

Live Training - 60 minutes

Questions and Answers Session