Webinar: Process Monitoring & Continuous Process Verification(CPV)
Webinar date 30 may 15:00 till 17:00
We have three speakers for you about our subject: Process Monitoring & Continuous Process Verification(CPV)
Jochen Giese (GSK)
Christine De Herde (GSK)
Kristel Janssens (Novartis)
Webinar is free for ISPE members
Chair ISPE CoP Benelux / Managing Director Sales & Finance at Trevalco
Tim Vertongen is a passionate life science professional with almost 20 years of experience. He started his career at Alcon (now part of Novartis) before entering consultancy. Tim has performed multiple projects in Belgium and the Netherlands at several clients with extensive periods at Pfizer and Prothya BioSolutions. He’s an all-round professional with experience in CSV, Engineering, CQV and QA. Currently Tim is Managing Director Sales & Finance at the life science consultancy company Trevalco and he uses his network and knowledge to support the sector as Board Member of the ISPE Belgium Affiliate vzw and Chair of the ISPE CQV COP.
GSK - Lead Statistician within global Quality organization
Jochen Giese is the lead Statician within global Quality Organization leading a global team statisticians supporting Quality and Manufacturing organization (Vaccines). Jochen has a PhS in Mathematica,
Christine de Herde
GSK - Senior Specialist Product and Process Validation Lifecycle
Christine joined GSK Vaccines in 2006. Christine was always part of the global team in charge of GSK vaccines life cycle management. Christine started working on the embryo of what we currently use to manage Continued Process Verification, evolving from simple manual tools to automated data consumption integrating statistical analysis and reports. Over the years Christine has also ensured within the team the maintenance of their data base, having covered several products and sites data migration. Currently global owner of Vaccines CPV analytical solution, Christine continues to seek additional data acquisition and to provide the right validated tools to our customers, embedded in a Gxp framework.
Novartis - Product Steward Lead
After completion of my Master Degree in Biochemistry I’ve obtained a PhD in Sciences at the Catholic University of Leuven, Belgium. Joining Alcon in Puurs (nowadays a Novartis site) in 2008 I’ve held several positions: In the Quality Department I worked as SQA Packaging Engineer responsible for Supplier Quality contacts and qualification activities of incoming packaging materials on the production lines. In 2011 I started in the MS&T (Manufacturing Science & Technology) department as Validation Systems Team Leader responsible for equipment requalification activities and media fill and later on switched to Contract Sterilization Coordinator where I managed a small group taking care of external (ethylene oxide and gamma irradiation) sterilization qualification activities of raw materials, packaging components and finished product. Since 2021 I’m working as Product Steward Lead which includes oversight of >70 different products produced in Puurs, data trending and launching improvement projects when needed. Throughout the years I’ve managed multiple Lean Manufacturing projects for which I’ve obtained a Lean Manufacturing degree equivalent to a Green Belt.