Biomanufacturing Facility Design: The Impact of Annex 1 and Contamination Control Strategy

Life Sciences, Pharma Manufacturing & Supply Chain,
  • Wednesday, September 13, 2023

In this webinar, the featured speaker will highlight the path to process efficiency and risk mitigation, in compliance with Annex 1 for the design and control of biomanufacturing facilities, along with a plan for integrating the Contamination Control Strategy (CCS). Contamination control plays a pivotal role in safeguarding biomanufacturing processes, and the revised Annex 1 regulations highlight the importance of implementing a comprehensive CCS rooted in Quality Risk management (QRM) principles.

The featured industry expert will share the value of a robust CCS. Attendees will discover how to proactively identify, scientifically evaluate and control potential risks to quality, ensuring that operations are optimized for success. In addition, attendees will discover how to calculate risk and establish mitigation strategies for high-risk scenarios. Participants will learn how to define critical control points and assess the effectiveness of design, procedural, technical and organizational controls and monitoring measures. The speaker will share invaluable insights into the six key focus areas that drive a successful CCS. This webinar presents a unique learning opportunity to establish risk elements through a meticulously planned strategy of identification, leveraging industry-proven assessment tools.

Register now to unlock the potential of a well-planned CCS and address contamination control practices that can help transform a facility’s performance and take biomanufacturing operations to the next level.


Jeff Odum, Genesis AEC

Jeff Odum, CPIP, Practice Lead, ATMPs and Biologics, Genesis AEC

Jeff Odum is the ATMPs and Biologics Practice Leader for Genesis AEC. He is a globally recognized SME in biomanufacturing facilities, with over 30 years of experience in consulting and operational roles. He has authored more than 70 technical articles, published four industry reference books and presented at more than 200 industry forums globally. A certified pharmaceutical industry professional, his projects have resulted in $3B+ in total installed cost for biomanufacturing operations, while leading the development of numerous industry guidance documents throughout his career.

Message Presenter

Who Should Attend?

Who should attend:

  • Design Engineers and Architects
  • Facility Engineers
  • Manufacturing Leads
  • Quality Managers
  • Compliance Managers
  • Project Managers
  • Development Engineers
  • Operations Specialists

What You Will Learn

Attendees will:

  • Discover the six key focus areas for a successful Contamination Control Strategy (CCS) effort
  • Learn how to establish risk elements through a well-defined strategy of identification
  • Utilize proven assessment tools used by the industry to calculate risk
  • Develop effective mitigation strategies for identified high-risk scenarios

Xtalks Partner

Genesis AEC

Since our inception, Genesis AEC, an award-winning architecture, engineering, and construction firm, has helped life sciences companies 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 for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality and safety to deliver unparalleled results.

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