In today’s regulated pharma and biopharma manufacturing environment, filter integrity testing is not just a compliance checkbox; it’s a critical control point that safeguard product quality, and patient safety. However, many organizations approach integrity testing with a binary mindset of PASS or FAIL.
This webinar challenges that paradigm by diving deeper into what integrity truly means beyond a single test result. We’ll explore why a more holistic, data-driven view of filter integrity is essential, and how quality risk management (QRM) principles must be embedded in how integrity systems are selected, qualified, operated, and interpreted.
Join us to move beyond pass/fail and be ready to build an ecosystem that brings confidence in your manufacturing process, product quality, and safety.
In this webinar, you will learn:
- Key Aspects of Filter Integrity Testing, recent regulatory trends, and Quality Risk Management (QRM).
- How an Automatic Filter Integrity Tester be used in QRM Environment
- Is it sufficient to look at Pass/Fail Results or is there more to it
Speakers
Braj Nandan Thakur
Merck
Global Product Manager, Automation
Braj Nandan Thakur is the global product manager for data analytics and automation software. He works to build roadmaps and strategies for software that meet and anticipate industry needs and assist companies in their digital transformations. Braj has implemented enterprise-level digital solutions from R&D through to manufacturing. He holds a master’s degree in bioinformatics from the University of Allahabad and a PGDM from the Institute of Management Technology, Hyderabad, India.
Somasundaram G (Som)
Merck
Senior Consultant
Som is a consultant with customers for regulatory compliance, closed processing, and other areas in biopharmaceutical applications. He is also a member of PDA and ISPE industry associations. Som has worked in different functions within Merck for the last 19 years, including heading technology management, tech service, BioReliance® filter validation lab, commercial role, and business development areas. He also worked for a year in QA/QC as well as obtained one year of academic experience in microbiology.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:Thu, September 25, 2025 2:00 PM CEST
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