Pharma’s Journey to Digital Manufacturing and Supply
March 4, 2024@2:00 pm-March 6, 2024@4:30 pm
Join us for a comprehensive exploration of cutting-edge technology applications and use cases together with regulators.
The ISPE D/A/CH workshop “Pharma’s Journey to Digital Manufacturing and Supply” is a site visit and a two-day workshop at Lonza AG in Visp, Switzerland.
Participants will engage in in-depth discussions on Data, Artificial Intelligence, and Machine Learning tools, including real-world case studies and their regulatory implications. Our expert speakers will address the critical issues of quality and regulatory risks associated with technology implementation and model translation, while also emphasizing effective data management and its significance in regulatory assessments. Furthermore, the workshop serves as a platform to enhance mutual understanding and transparency between industry leaders and regulatory authorities, therefore fostering invaluable collaboration within the pharmaceutical manufacturing sector. To kickstart the workshop, we offer a limited number of participants the unique opportunity of a site visit to Lonza’s cutting-edge facilities in Visp on the first day. This visit will provide an early glimpse into the practical application of the discussed technologies in a real-world pharmaceutical manufacturing setting.
You will receive recommendations for your accommodation and detailed travel information after registering for the workshop.
Objectives and Agenda
- Deep dive into Data, Artificial Intelligence (AI) and Machine Learning (ML) tools and technologies in Pharma manufacturing
- Discuss AI model case studies and related regulatory implications
- Address quality / regulatory risks and risk management approaches for technology implementation and translation of models into the real world
- Elaborate how to convey the generation, control and management of data, and to distinguish meaningful content for regulatory assessment in an application and for inspection
- Increase mutual understanding and transparency between industry and regulatory agencies
|March 4,||Site Visit at Lonza, Visp, Switzerland (Biologics Facility, Small Molecules Facilities, mRNA/Ibex Solutions®) – limited number of participants|
|March 5,||Welcome, Keynote Presentations and Panel Discussion|
|Session 1: Data / AI, ML Strategies & Use Cases in Biotechnology|
|Session 2: Data / AI, ML Strategies & Use Cases in Development, Technology Transfer and Launch|
|March 6,||Session 3: Data / AI, ML Strategies & Use Cases in Packaged Drug Product Manufacturing|
|Session 4: Harnessing Digital Twins for Quality by Design: Real-World Applications and Business Cases|
|Session 5: Translating Innovative Digital Paradigms for Adoption and Implementation|
|Session 6: Closing Panel Discussion|
Find the full agenda here.
The workshop is tailored for mid-senior level managers and professionals involved in the digital transformation of Pharma manufacturing and supply.
04. – 06. March 2024
3930 Visp, Switzerland
Site Vist at Lonza AG is limited to 39 participants. The workshop accomodates 140. First come first serve!
Cost per person (excludes accommodation):
Euro 450.- (ISPE member);
Euro 750,- (ISPE non member)
All registrations must be done online.