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
Small Group Discussions
Technical Presentation
Technical Presentations

Learning Objectives

  1. 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
  2. Discusses Closed Processing in CNC ballroom design to provide increased flexibility of operations
  3. 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
Deep-Dive into Closed System Design: A Workshop to Introduce the Closure Playbook to Pharma Industry


Jeffery N. Odum, CPIP
Practice Leader: ATMPs & Biologics
Genesis AEC

Webinar Rates


Member Free
Nonmember   $149 

Buy on DemandView Now

ISPE Membership Benefits

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.

Benefits include:

  • Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
  • Member-only discounts on Guidance Documents, Conferences, and Training
  • Pharmaceutical Engineering® magazine
  • Communities of Practice access to pharma professionals in specific topics from around the world
  • And more
Join Today