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cGMP 101: Translation of cGMPs into Facility Design Requirements
Current Good Manufacturing Practices, or cGMPs, provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. In this presentation, experts in cGMP facility design from Precis Engineering, Kristina Pumphrey, PE, Tim Lisle, AIA, and John Volence, PE, CEM will discuss the fundamentals of cGMPs and how they translate into pharmaceutical facility design requirements imposed by the FDA. This presentation is best suited for the pharmaceutical professional who would like to broaden their understanding of cGMPs in facility design.
Speakers:
Kristina Pumphrey, PE
Director of Process Engineering, Precis Engineering
Kristina Pumphrey, PE, is an accomplished Process Engineer with more than 20 years of experience in the pharmaceutical and biopharmaceutical industries. Her broad knowledge base, spanning industry technologies, includes material handling, potent compounds, and hazard analysis. At Precis, Kristina is responsible for translating user requirements into a working facility by specifying the equipment, controls, and interconnecting piping into an efficient layout that meets cGMP and regulatory requirements and results in a quality product. A certified Lean Six Sigma Black Belt, Kristina uses her lean manufacturing expertise to help clients plan for the future by improving operational efficiency. She extends her pharma industry leadership to the professional community as a member of ISPE, member of the Biotechnology COP Steering Committee and past President of the Delaware Valley Chapter. She holds a Master of Science in Management and Technology from Widener University and a Bachelor of Science in Chemical Engineering from the Pennsylvania State University.
Tim Lisle, AIA
Director of Process Architecture, Precis Engineering
Tim Lisle, AIA, is an accomplished Architect with more than 40 years of experience in his field. Tim is expert in the programming, planning, and design of highly technical facilities for corporate and government clients in various markets, including life science, technology, industrial, and public safety. As Director of Process Architecture at Precis, Tim leads the process design efforts on complex pharmaceutical and biotech projects across a range of research & development, drug development, and manufacturing facilities. Tim holds dual Bachelor of Science degrees in Architecture and Environmental Science from Auburn University and architectural registration in six states. He is a member of the American Institute of Architects (AIA), National Emergency Numbers Association (NENA), Lower Merion Township Uniform Construction Code Appeals Board, and Habitat for Humanity Philadelphia Repair Committee, and serves as a visiting architectural critic at Drexel University, Temple University, and the University of Pennsylvania.
John Volence, PE, CEM
Principal - Sr. Director, Mechanical Engineering, Precis Engineering
John Volence leads Precis’ mechanical engineering department, overseeing project execution, as well as quality control and training of the department. A mechanical engineer with more than 14 years of professional experience in pharmaceutical, biotech, and higher education projects, he has completed complex HVAC and MEP designs and assessments throughout the U.S. A Certified Energy Manager, John is an expert in energy modeling and analysis, and design of complex HVAC systems. John is an active member of the Association of Energy Engineers (ASHRAE) and the International Society of Pharmaceutical Engineering (ISPE). He holds a Bachelor of Science degree in Mechanical Engineering from Penn State University.
Registration Information:
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COST |
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ISPE Members |
$70 |
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Non-Members |
$90 |
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Emerging Leaders/Student |
$45 |