In collaboration with Biozeen.
Date: September 16th, 2025
Time: 12 PM to 01:30 PM (CET)
Description: As sterile filtration remains a critical control step in biopharmaceutical manufacturing, regulatory bodies are raising the bar on what constitutes a robust and compliant filter validation program. This webinar will explore the evolving expectations from global regulators and auditors, and how organizations can adapt through advanced validation practices and dual filter strategies.
Designed for professionals in quality, regulatory, and process development functions, the session will address both foundational principles and cutting-edge developments in sterile filter validation.
Key Highlights:
- Importance of Filter Validation
- Common pitfalls and how to avoid audit observations
- Recent advancements in bacterial retention (BR) testing
- Troubleshooting filtration failures: root causes and corrective strategies
- The science and application of dual filter validation – when, why, and how
- Case insights and industry best practices
Speakers Dr. Christina Rosy J. & Mr. Aswath Kumar
Biozeen
Speaker 1
Name
Dr. Christina Rosy J.
Position
Manager – Training
Biography: Dr. Christina Rosy J. brings over 15 years of experience in training, and professional development. Her research had focused on antimicrobial resistance, with significant contributions toward the design of alternative therapeutics that inhibit iron sequestration in bacteria – offering a promising strategy to combat antibiotic resistance.
At Biozeen, Dr. Christina leads key initiatives in curriculum development, hands-on training programs, and industry collaboration. She plays a crucial role in equipping professionals with the skills needed to operate in real-world bioprocessing environments. Her areas of expertise include upstream and downstream processing and sterile operations in biopharmaceutical manufacturing.
Dr. Christina is passionate about nurturing talent for the biopharmaceutical industry and is committed to aligning Biozeen’s training offerings with evolving global standards and industry expectations.
Speaker 2
Name
Mr. Aswath Kumar
Position
Manager – Biozeen Regulatory Services
Biography: Aswath Kumar is a passionate Validation Specialist with over 18 years of experience in the pharmaceutical and life sciences industry. With strong technical skills and a systematic approach, he has led projects in aseptic processing, cleanroom qualification, and computerized systems validation (CSV).
He is recognized for his detail-oriented work and knowledge of FDA, EMA, MHRA, and ICH guidelines, ensuring compliance with global standards. His expertise covers sterile filter and equipment validation, PDA Technical Report No. 26, autoclave validation, FDA query handling, breakdown maintenance, cleanroom validation, and audit and customer complaint management.
