September 26, 2018   
Gillette Stadium

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Risk Based Approach to GMP Manufacturing Facility Design

12:00 PM – 1:00 PM |

The recent caution statement issued by the FDA advising companies to establish well-controlled manufacturing processes highlights the difficulties to consistently produce high quality therapies that are safe and effective.  This challenge is made more difficult by the variability in materials, methods, and controls necessary to perform these processes.  While much focus has been on risks associated with manufacturing operations for all forms of cell based therapies, we have found the integration of manufacturing science, facilities operation, and facilities design into a single risk analysis is best suited to identify variables and risks, and then to devise strategies to mitigate these risks while promoting the production of high quality cell based products.  This presentation will discuss an integrated approach to the risk analysis process used for individual patient, single product, or multi-product facilities and will highlight how manufacturing science and pharmaceutical operations inform facility design to create an enhanced procedures, improved engineering controls, design upgrades or a combination of all three.

This presentation will discuss the risk assessment process, and how it integrates with the design of manufacturing facilities for FDA-regulated products.  It will demonstrate how the process takes a holistic examination of risk, and how the risk assessment generates improvements in operating procedures, manufacturing process flow, engineering infrastructure, and the facility design process.  It will highlight both benefits and pitfalls of this exercise and will provide examples of how the risk assessment influences and justifies design changes to protect patient safety.  Lastly this presentation will review how the risk assessment procedure can greatly enhances the facility design process resulting in the construction of improved manufacturing environments to consistently produce high quality therapies that are safe and effective.

Speaker: Jim Levin | Senior Strategic Lab Planner, Perkins + Will

Jim Levin has been involved with the design and operations of manufacturing facilities for over 30 years.  He planned, constructed, and operated GMP facilities at commercial and academic institutions that were essential to investigative clinical trials and subsequent marketing approvals for products and medical devices in the United States and Europe.  He has been able to utilize his background in veterinary medicine and pharmacology to develop innovative facilities for commercial product production.  More recently he has transitioned into using is experience to help clients design and build GMP manufacturing facilities for a wide array of international products.  His experience in managing manufacturing and regulatory operations has allowed him to operate at the intersection of these two skills to help clients understand and develop risk-based approaches to individualized and novel life saving therapies.