Evolving World of Single Use Manufacturing Technology 


Javier Lozano, PM Group -

Presentation Title: Benefits of industry wide single-use standardization

Javier is a Chemical Engineer graduated from the University of Valladolid, Spain. Javier has more than twenty years of experience in the process design of pharmaceutical facilities. His experience is a mix of site based engineering roles as well as engineering consultancy positions.

Javier is currently leading the process-mechanical department for PM Group Birmingham (UK) operations as Head of Process Engineering. As part of this role he manages and oversees the process design of all pharmaceuticals projects managed by PM Group in the UK.

Additionally, Javier is the Single-Use Technology expert for PM Group globally and as such he gives support to projects using the technology globally across the group. As part of this role he is also the technical lead for the Standard Disposable Design, SDD(TM), initiative providing technical support and helping the SUT suppliers in the development of their solutions related to the initiative.

Chris Smalley, ISPE Disposable Core Team member, PDA Science Advisory board member, Consultant at Valsource.

Presentation title: ISPE Disposables COP SMEs: Chris Smalley and Dharti Pancholi - Disposables - leachables & Extractables

Chris Smalley is a consultant for Valsource, focused primarily on Compounding Pharmacies. His expertise includes Single Use Systems and Aseptic Operations. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager. Chris is a graduate of the Philadelphia College of Pharmacy of the University of the Sciences in Philadelphia. His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University. Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board. Currently he is a member of the ISPE Disposables CoP.

Dharti Pancholi, Co-Chair, ISPE Disposable, Executive Vice President and Global Managing Director at PharmEng Technology

Presentation title: ISPE Disposables COP SMEs: Chris Smalley and Dharti Pancholi - Disposables - leachables & Extractables

Dharti is an experienced executive leader with strategic business perspective as well as technical knowledge. Dharti possess Masters’ degree in chemical engineering with emphasis in biotechnology and over 2 decades of experience. Dharti has spent most of her career working in the biotech-pharmaceutical industry in both engineering / consulting service providing firms and user (owner) side companies. Dharti’s early career for ~10 years includes being employed with three user side public and private companies, where she successfully led multiple biotech, vaccine and API processes from late stage R&D to clinical and commercial manufacturing. For past ~10 years, Dharti has been involved with providing consulting services to many bio-pharma companies primarily within USA, and for some projects in Europe and Asia. Her technical expertise spans from process engineering, process development, engineering and project management,

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