Christian Wölbeling is Executive Industry Advisor & Senior Strategic Account Manager, at Körber Pharma Software based in Lüneburg, Germany. Körber Pharma Software is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. He holds a Master Degree in Mechanical Engineering. Since more than 30 years working in Life Sciences Manufacturing IT, Christian has had great experience in all GMP related processes.
He has broad activities inside the ISPE as Founder & Chairman of the CoP “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member, APQ Core Team Member, European Leadership Team / ELT Member and was named as “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine 2020.
The 2019 ISPE Europe Pharma 4.0™ Conference held in Manchester, UK, on 20–21 November 2019 was attended by 300 participants, all of whom contributed to the growing momentum for
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...
This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.