This Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components. Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. The focus of the presentation will be on qualifying Disposable for their appropriate use in a process, with particular emphasis on issues that regulators have expressed concerns about, including Extractables and Leachables, and highlighting criteria to select and qualify Single-Use components. The evaluation emphasizes risk management methods to identify the Single-Use components that are best qualified to meet the requirements of your processes.
Chris Smalley, ISPE Disposable Core Team member, PDA Science Advisory board member, Consultant at Valsource.
Chris Smalley is a consultant for Valsource, focused primarily on Compounding Pharmacies. His expertise includes Single Use Systems and Aseptic Operations. 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-COP Founder, Omni Consulting Chief Operations Officer at Advent Engineering Services, USA.
Dharti possess Masters’ degree in chemical engineering with emphasis in biotechnology and ~20 years of experience focused in biotech-pharma industries. Dharti’s early career for ~10 years includes being employed with three companies, and for past ~10 years, Dharti has been involved with providing consulting services.