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.
*ISPE Membership is required for these registration rates.
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