Webinar

Webinar: The Impact of Annex 1 & Contamination Control Strategy on Facility Design

Are you ready to elevate your biomanufacturing processes to the next level? Listen as our ATMPs and Biologics Practice Lead, Jeff Odum, CPIP, guides you through the path to achieving process efficiency and risk mitigation while ensuring compliance with Annex 1 regulations.

Unlock Process Efficiency and Risk Mitigation with Annex 1 Compliance and a Robust Contamination Control Strategy

Tune for these four key takeaways:

1. Comprehensive Compliance: Learn how to navigate the intricate landscape of Annex 1 compliance, ensuring your facility adheres to the latest regulations while maintaining optimal efficiency. Understand how a robust Contamination Control Strategy (CCS) rooted in Quality Risk Management (QRM) principles can be your key to success.

2. Proactive Risk Management: Gain insights into proactively identifying, scientifically evaluating, and controlling potential risks to quality. Ensure your operations are optimized for success with effective risk mitigation strategies.

3. Critical Control Points: Learn how to define critical control points and assess the effectiveness of design, procedural, technical, and organizational controls and monitoring measures.

4. Industry-Proven Tools: Explore industry-proven assessment tools and strategies to establish risk elements through a meticulously planned identification strategy. Address contamination control practices that can transform your facility’s performance and take your biomanufacturing operations to the next level.

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About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.