In today’s pharmaceutical and biotech landscape, contamination remains one of the most critical — and costly — risks facing cleanroom operations. Headlines like the 2009 Genzyme case, which resulted in a $175 million penalty and forced production shutdowns, underscore the devastating financial and patient safety consequences of inadequate contamination control. From microbial threats to particulate infiltration, facilities that fail to adopt proactive, multi-layered defenses are exposed not only to regulatory actions but also to reputational damage, loss of product integrity, and patient harm.
This presentation, led by industry expert David Grote, introduces a defense-in-depth strategy grounded in real-world application and regulatory best practices. Attendees will explore the foundational role of proactive risk assessments, including how tools like Failure Mode and Effects Analysis (FMEA) can uncover hidden vulnerabilities. From cleanroom layout design and gowning procedures to filtration and equipment cleaning protocols, each layer of control will be examined in detail — offering a comprehensive look at how to build and maintain robust contamination barriers.
Participants will gain practical insights into how to safeguard their cleanrooms using smarter controls, better training, and improved material flow. Case studies — including the use of Dycem mats for particulate control — illustrate real-life contamination prevention successes. Additionally, the session covers how to secure your supply chain, leverage real-time monitoring for immediate intervention, and implement strong CAPA investigations to ensure long-term solutions and compliance with global GMP regulations.
Key Learning Objectives
- Understand the Principles of Multi-Layered Contamination Control: Participants will learn how to apply a defense-in-depth approach by identifying and implementing layered controls across people, processes, equipment, and environments to mitigate contamination risks in cleanroom and production settings.
- Apply Risk Assessment Tools to Strengthen Process Integrity: Attendees will gain practical knowledge of risk analysis methods such as Failure Mode and Effects Analysis (FMEA) to proactively uncover, prioritize, and address potential contamination points in their operations.
- Enhance Compliance and Prevention Strategies Through Design and Behavior: Learners will explore how cleanroom design, gowning protocols, equipment layout, and human behavior influence contamination control, and how to optimize each for regulatory compliance and operational excellence.
Don’t wait for a failure to trigger change — register today to learn how to proactively protect your facility, your products, and your patients. This webinar is ideal for quality assurance professionals, cleanroom managers, and compliance leaders looking to sharpen their contamination prevention toolkit and strengthen their site’s risk posture.
