In The News
Webinar: The Impact of Annex 1 and Contamination Control Strategy on Biomanufacturing 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.
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.
3. 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.
4. Critical Control Points: Learn how to define critical control points and assess the effectiveness of design, procedural, technical, and organizational controls and monitoring measures.
5. Six Key Focus Areas: Discover the six key focus areas that drive a successful CCS, giving you a comprehensive understanding of best practices.
6. 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.