This webinar addresses the critical challenges pharmaceutical and biopharmaceutical manufacturers face when implementing TOC systems, from technical concerns to regulatory acceptance.
What You'll Learn:
- TOC & PAT Fundamentals: Understand how TOC works as an ideal PAT implementation tool, offering real-time quality monitoring with superior speed and sensitivity
- Cleaning Validation Applications: Discover how TOC addresses traditional method limitations through rinse water analysis, swab sample testing, and real-time monitoring
- Regulatory Compliance: Learn what regulators expect, validation essentials (specificity, linearity, accuracy, LOD/LOQ), and documentation requirements for inspection readiness
- Implementation Best Practices: Navigate planning, risk assessment, installation, qualification, method validation, and ongoing compliance
- Real-World Success: Explore case studies highlighting key success factors and ROI benefits
Presenters: Keith Bader & Tony Saavedra
Keith Bader provides high-level consultation to Hyde’s Engineering’s clients in topic areas ranging from strategic quality and validation documentation architecture to detail-oriented support such as design of experiments and supporting study design. He has expertise in the implementation of online TOC instruments and process analytical technologies for clean-in-place systems, as well as the translation of bench-scale cleaning process development data to full-scale manufacturing systems.
Tony Saavedra, MBA, is the Life Sciences Product Manager for Veolia's Sievers Analytical Instruments, specializing in TOC software and instrumentation. He joined the Sievers product line at GE Analytical Instruments in 2011 in field service, later leading the North American Services team overseeing technical support, factory service, and refurbishment operations.