Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...
An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...
As part of the 2023 ISPE Annual Meeting & Expo, the 2023–2024 ISPE International Board of Directors was introduced and the gavel was passed to a new Chair on 16 October 2023 during the 2023 ISPE Membership Meeting and Awards Lunch in Las Vegas,...
Each year at the ISPE Annual Meeting & Expo, ISPE bestows the ISPE International Honor Awards on a select group of individuals and groups who have gone above and beyond to support ISPE. The Affiliate and Chapter...
Erich H. Bozenhardt is the Associate Director of Process Engineering in Regenerative Medicine Operations at United Therapeutics. Erich is an experienced bioprocess subject matter expert and internationally recognized authority in the areas of cell and gene therapy and bioprocessing. He has published more than 30 technical papers and is a frequent presenter at conferences.
