Going digital in manufacturing & laboratory operations
Join us on November 12th, 2024 in Gorinchem (NL), for an exciting GAMP event on “Going digital in manufacturing & laboratory operations”. This event will focus on real use cases to inspire you with your future implementations. Learn from experts in the field about Digitalization in manufacturing & Laboratory operations and use their knowledge to improve your quality, efficiency, and safety. We are working to have the best experts presenting on the best topics. Below a first glance on the expected topics:
1. Navigating the intersection of Agile, Digital & Compliance in Pharma
2. Demonstration on how to apply AI in validation tooling.
3. Implementation and use of Kneat which includes the advantage of e-validation instead of paper within e.g. for lab or shop floor validation.
4. OT/IT connectivity use case and the advantages for real time scheduling and predictive maintenance in the life science industry.
Attendees will have the opportunity to ask questions and gain valuable insights from experts in the field. Don't miss out on this opportunity to network with industry leaders and gain a deeper understanding of the future of the life sciences industry. Register now on our website and be at the forefront of innovation!
This event, sponsored by Agidens Gorinchem, will be held in Hotel Gorinchem, the Netherlands.
The event is open for both ISPE members (free of charge) and non-ISPE members (€40). Registration is required.
Event Properties
| Event Date | 12-Nov-2024 14.00 |
| Event End Date | 12-Nov-2024 20.00 |
| Capacity | 80 |
| Registered | 25 |
| Individual Price | €40.00 |
| Location | Hotel Gorinchem |
Agendas
| 13h30 |
Walk-in and registration |
| 14h00 |
Welcome by GAMP COP Benelux Co-chair Gerard Gorka |
| 14h05 |
Welcome by the SponsorIntroduction and welcome by Chris Assen and Pieter Tilkens of Agidens, Gorinchem (NL) |
| 14h15 |
Navigating the intersection of Agile, Digital & Compliance in PharmaBy Kees Mensch (The Digital Capability Company) |
| 14h45 |
Demonstration on how to apply AI in validation toolingBy René van Opstal (Optimum Quality) |
| 15h15 |
Data Integrity: What you should consider during your LIMS implementationLudo Staelens (UCB) |
| 15h45 |
Break: time for a drink and networking |
| 16h15 |
tbdMarco Consales (Labware) |
| 16h45 |
tbd(Agidens) |
| 17h15 |
Short (bio)break |
| 17h30 |
Kneat implementation and use within MerckBy Ron van Uden (MSD Biotech), including a demonstration |
| 18h00 |
Unlocking efficiency in Life Science ManufacturingThe Benefits of IT/OT Convergence. By Kristof Hendrickx (Emerson) |
| 18h30 |
Q&A, wrap-up and closing |
| 18h45-20h00 |
Dinner and networkingPlease indicate during registration if you like to join (we don't like to waste good food). Thanks! |
Speakers
Natasja Bastiaens
GAMP COP Benelux - Chair
Natasja is a demonstrated people leader with 20+ years of experience in the life science industry covering different roles (Team Lead, Project Manager, Coach, Compliance Officer,...) and expertises (CSV, IT Compliance, Cyber Security,...) in different GxP environments. She`s part of the ISPE GAMP COP Benelux Board since 2018.
René van Opstal
Optimum Quality
René is a very experienced consultant in the field of process automation, Computer Validation, MES, system selection and advise. Beside that, due to his large experience in the execution of projects (from design, implementation and project management) he is capable of leading a large group of people in engineering teams or customer project teams.
The current focus is on content based digital validation of systems, Using Microsoft DevOps with Modern Requirements.
Kees Mensch
Pertner @ The Digital Capability Company
Kees Mensch has over 30 years of experience in managing complex technical and IT systems. He holds a master's degree in Physics and has served as the Head of IT at NecstGen for the past four years. NecstGen, based in Leiden, the Netherlands, focuses on Advanced Therapy Medicinal Products (ATMPs) and aims to bridge the gap between academia and the pharmaceutical industry. Kees has worked in various fail-safe industries, including aerospace and manufacturing.
Kristof Heyndrickx
Sr. Business Development Manager @ Emerson
Kristof has more than 20 years experience in managing large complex technical projects with various stakeholders.
He holds a Master’s degree in Electronics Engineering and is working at Emerson since 2013. He helps industrial and pharmaceutical companies in their digitalization efforts, enabling them to understand and leverage the potential of existing technologies. Additionally, Kristof’s extensive network within Emerson allows him to highlight successful proven in-use digitalization projects in life science manufacturing.
Ron van Uden
IT/OT Compliance lead
Ron has over 20 years of experience in the pharmaceutical Industry as a CSV engineer, QA-IT and IT/OT Compliance Lead within Organon, Shering-Plough and MSD.
He is a KNEAT Power user and part of the MERCK KNEAT enhancement team, which have regular meetings with the KNEAT development team.
Ludovicus Staelens
Ludovicus is the Head of Bioanalysis at UCB, leading a team in developing and validating bioanalytical methods. With nearly 20 years at UCB, he specializes in pharmacokinetics, immunogenicity, and biodistribution using advanced technologies like LC-MS/MS, LBA and PCR.
