ISPE Insights x CoP Critical Utilities - sponsored by Novartis
Join the ISPE Insights x CoP Critical Utilities event, sponsored by Novartis, for students and young professionals in the life science industry.
Discover the crucial role critical utilities play in biotechnological and pharmaceutical processes. Delve into topics such as qualification, automation and contamination risks and gain valuable insights into regulatory requirements. Look forward to hands-on learning during exclusive tours of a solid oral dosage form production facility and a water treatment plant – accompanied by experts from the ISPE Critical Utilities Community of Practice and Novartis.
Our speakers
Patrick Zipfel
Head Process & Project Engineering at Novartis Pharma Produktions GmbH
Patrick Zipfel has over 25 years of experience in the pharmaceutical industry. His extensive career spans 20 years dedicated to infrastructure and project engineering.
Before joining Novartis, Patrick worked for almost 8 years at GP Grenzach Produktions GmbH (Bayer HealthCare), where he held the position of Head of GPET. In this role, he was responsible for GMP media, infrastructure and electrics.
Patrick has been a key person at Novartis Pharma Produktions GmbH in Wehr since 2013. He was initially responsible for project engineering, and over time his responsibilities expanded to include automation and process engineering. He has successfully managed several complex “A-projects” as a senior project manager.
Patrick has also been an active member of the ISPE CoP “Critical Utilities” since 2011, which shows his commitment to industry standards and best practices. His leadership and expertise continue to drive innovation and excellence in pharmaceutical technology.
Stefanie Blioch
Process Utilities Engineer
Stefanie Blioch is a Process Utilities Engineer at CRB and brings a wealth of knowledge and experience to our event. Stefanie holds an MSc in Biotechnology and is actively involved in the ISPE Emerging Leaders and Women in Pharma organizations. She is also co-initiator and organizer of the Insights event.
Before joining CRB, Stefanie worked in construction project management. Over the last five years at CRB, she has developed from a process engineer to a specialist in clean utilities engineering, with a focus on the design of clean media generation, storage and distribution systems.
Stefan Raabe
Head of SAM LSI at Endress+Hauser (Schweiz) AG
Stefan Raabe has decades of expertise in the field of critical utilities. Stefan has been actively involved in project engineering and system planning for PW/UPW systems in both the pharmaceutical and semiconductor industries since 1995.
His journey with ISPE began in 2001, and in 2005 he joined the newly formed CoP “Pharmaceutical Water and Steam” (now Critical Utilities). His leadership qualities and commitment were recognized, and he has been team leader since 2023.
In 2011, Stefan joined the strategic business unit of Endress+Hauser, and since 2020 he has been leading the LSI SAM team. His extensive experience and commitment to excellence make him a valuable speaker at our event.
Christian Graf
Lead Clean Utilities Eningeer at ips
Christian Graf has over 20 years of experience in the pharmaceutical and biotechnology industry. With a technical background in biotechnology engineering, Christian has been an active member of ISPE since 2006 and a member of the CoP Critical Utilities Steering Committee since 2019.
Christian’s career includes heading the downstream department at a biotech start-up for five years, project management in the pharmaceutical industry for the planning of pure media plants and twelve years as a plant engineer and head of an engineering team. He has been with IPS Germany since 2003 and heads the Clean Utilities Engineering Team.
Dennis Branco
Automation Engineer at Novartis Pharma Produktions GmbH
Dennis Branco is an automation engineer at Novartis Pharma Produktions GmbH and has been an integral part of the team since 2013. He currently works in the process and project engineering department and has extensive experience in the areas of maintenance, infrastructure, production technology and automation.
Dennis is the first point of contact for automation projects as a project manager and supports projects as a specialist manager for electrics and automation. Among other things, he is responsible for online monitoring and the building management system in Wehr.
Stephan Stocker
Technical Transfer Leader (MS&T) at Novartis Pharma Produktions GmbH
Stephan Stocker is the Technical Transfer Leader (MS&T) at Novartis Pharma Produktions GmbH and has more than 15 years of experience in the pharmaceutical production of sterile and solid dosage forms. Since 2011, Stephan has held various operational roles in Manufacturing, Science & Technology at Novartis in Wehr.
Stephan has extensive knowledge of process and cleaning validation, statistical process monitoring and change and deviation management. He was responsible for product relocations and the preparation of new products for submission and market launch in collaboration with the development department.
Ludovic Brech
Senior Engineer at Chemgineering Switzerland AG
With an impressive 24 years of professional experience at Chemgineering Switzerland AG, Ludovic Brech is currently a Senior Engineer in the BDS Division and Head of the CU Practice Group. Since joining the company in 2003, Ludovic has managed numerous projects, including leading project teams for Clean Utilities, global technical support for standardization and managing CU projects as a general contractor, GP or in recruitment. His expertise includes engineering, commissioning and qualification (C&Q) as well as validation support.
Ludovic has been an active member of ISPE since 2017 and a member of the Community of Practice (CoP) Pharma Water & Steam since 2022. His extensive knowledge and experience make him a valuable asset for any project and a trusted leader in his field.
Jochen Schmidt-Nawrot
Senior Process Utilities Engineer at CRB
Jochen is a recognized thought leader in the ultrapure water systems industry
ultrapure water systems for the pharmaceutical industry with almost 30 years of professional experience. He takes great pride in understanding the needs of the end user in order to develop the optimum water system design in terms of quality and economy. Prior to joining CRB, Jochen worked for innovative and leading suppliers of ultrapure water systems in various markets, giving him a unique perspective on system designs.
As a Fellow in Process Utilities, Jochen focuses on the design, process selection and sizing of complete water systems for the generation, storage and distribution of PW, WFI and clean steam.
Jochen is an active member of ISPE and its Global Steering Committee
for Critical Utilities. He is co-author of the ISPE Good Practice Guide for
“Membrane-based WFI generation” and the GPG for “Ozone sanitization”.
Agenda
- Arrival and welcome: The Wehr plant, 9.30 am – 10.00 am
- Project introduction & cost analysis: How do you approach a CU project? 10.00 am -10.30 am
- QualificationDQ/IQ/OQ – what does that mean? 10.30 am – 11.00 am
- AutomationWhat does the automation of a modern water system look like? 11.15 am – 11.45 am
- Movie OSD 11.45 a.m. – 12.00 p.m.
- Lunch 12.00 p.m. – 1.30 p.m.
- Tour of the factory 1.30 p.m. – 2.30 p.m.
- Coffee Break 2.30 pm – 2.45 pm
- Contamination risks and current regulations: What’s important? 2.45 p.m. – 3.30 p.m.
- Q&A session with the speakersWhy should you join a CoP? 3.35 pm – 4.00 pm
- Q&A and wrap up (end approx. 17:00)
- OptionalNetworking Dinner
Key Details
Target Group
The specialist discussion is aimed at students and young professionals from all areas of the pharmaceutical industry.
Date
06.05.2025 09:30 am – 5:00 pm
Location
Novartis
Öflinger Str. 44
79664 Wehr (at the gate)
Language
The workshop will be held in English.
Workshop size
The number of participants is limited to 30 in order to ensure an efficient exchange.
Participation fee
Participation is free of charge.
Registration
Registration can only be done via the online form. Use the following button to go to the registration page