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.
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.