Deep-Dive into Closed System Design: A Workshop to Introduce the Closure Playbook to Pharma Industry
Extended Learning
Learning Level: Advanced
Session Length: 2 hours
Twenty years ago, ICH Q7A was published. This regulatory guidance document established a set of goals that would drive the design and operation of biomanufacturing facilities for decades to come. It also brought to the forefront the use of closed systems as a strategy for enhancing process consistency and reliability and for making products safer for the Patient. This playbook has been developed to aid in optimizing decision-making when designing, constructing, or modifying bioprocessing equipment, processes, or the biomanufacturing facility. The primary principle for this playbook is to utilize a risk-based approach for determining key facility and process attributes and controls.
The session will use an interactive workshop format to guide attendees through the use of risk-based closed system design. There will be opportunities for attendees to break out into smaller groups to work through examples and report findings to the larger group of attendees.
Small Group Discussions
Technical Presentations
Problem-Solving
Learning Objectives
- Express how closed processing provides for a biomanufacturing program that is ultimately safer to the patient while enabling new facilities to be designed with reduced CapEx and OpEx
- Discusses Closed Processing in CNC ballroom design to provide increased flexibility of operations
- Provide a ‘roadmap’ for the industry to successfully develop a robust strategy for facility design and a strategy for the scientifically based assessment and validation of this design
Speakers
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