february, 2015

19feb5:30 pm8:30 pmISPE Myth Busting Biopharm Facility Designs through Leading Edge Concepts


Event Details

Attend the live program at Genzyme Center in Cambridge, MA or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA. The programs at all three locations will include a networking reception including appetizers.

The emerging trends in our highly regulated industry require a unique approach and broad experience base to optimize facility designs and implement process improvements in a validated environment. This event brings three industry experts together to provide diverse perspectives on trends, techniques and strategies to implement world-class facility operations. There is a revolution within the Biotech and Pharmaceutical Industries where sharing best practices will enhance standards to address emerging issues such as process complexity, adoption of new technologies, and contamination risks. This collaborative event brings these unique perspectives together, covering:

Facilities Optimization Design Perspectives
The first presentation will illustrate areas where facility design is impacted by the number of products in the pipeline, operational ease, operating costs, and the impact of yield changes. Facility Design Optimization is often overlooked or not fully addressed when developing a facility for a specific process. Designing an optimal facility  requires the input from all stakeholders and incorporating critical input ensuring compliance and consideration for process, risk(s), compliance and operations into account.

Biotech Facility Best Practices
The second presentation focuses on Biotech manufacturing facilities with complex and technical cleaning requirements. Real World examples  of FDA requirements, Quality Practices and Consultant Advice in the Biopharm industry that have contributed to high costs, poor facility hygiene and increased operator and building hazards. There is Best Practice that keeps patients and operators safe and complies with cGMPs will be shared. These Best Practices will be coveredin this presentation, where common myths will be busted.

Facility Optimization Considerations
The closing presentation will provide broad range of consideration exploring Facilities Optimization from the Facilities Management and Facilities Engineering viewpoint. We hear a lot about design, construction and optimization of layout, utilities, capacity and processing areas of new facilities. This presentation looks at a wide range of optimization considerations, including; maintenance programs, calibration and maintenance intervals, capital budgets and resources, facility and utility robustness, process optimization, and evaluations techniques for these categories. Considerations to maximize capital budgets and thoughts on optimal facilities team composition to successfully operate these complex facilities – what? This sentence is missing a closing.

Please join these industry experts and our distinguished panel to learn more about these topics and participate in a Q&A session at this ISPE Boston educational event.


(Thursday) 5:30 pm - 8:30 pm


Embassy Suites - Boston Logan Airport

207 Porter Street Boston, Massachusetts 02128