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 Van der Valk 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 | 68 |
| Individual Price | €40.00 |
| Location | Van der Valk 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 implementationLudovicus Staelens (UCB) |
| 15h45 |
Break: time for a drink and networking |
| 16h15 |
The bi-directional interface between LabWare LIMS and Kober Pas-x MES suiteBusiness case including technical details on the functioning, by Mark Gonzalez (LabWare) |
| 16h45 |
ValidAId: supercharging the validation process with GenAIJeroen Arends and Lien Brusselaers (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 Heyndrickx (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
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.
Gerard Gorka
GAMP COP Benelux - Vice-chair
Senior Project manager & Consultant within life sciences.
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 MSD
Ron has over 20 years of experience in the pharmaceutical Industry as a CSV engineer, QA-IT and IT/OT Compliance Lead within Organon, Schering-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
Head of Bioanalysis @ UCB
Ludovicus is 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.
Jeroen Arends
Sr. GxP/CSV Compliance Engineer
With over 15 years of invaluable experience in the pharmaceutical industry and a Bachelor's degree in Analytical Chemistry, Jeroen is known for his strategic approach to solving complex problems and driving organizational success. Understanding regulatory requirements and industry trends, he is committed to excellence and driving meaningful change. He’s eager to collaborate with like-minded professionals to develop innovative solutions.
Mark Gonzalez
Technical Director at LabWare
Specialist in Laboratory Automation solutions such as LIMS and ELN. Involved in Development, Sales, Implementation and Support. Active in areas related to Compliance, such as Pharmaceutical and Clinical regulations. Experienced with large scale, multi-national projects.
Lien Brusselaers
Innovation Consultant @ Agidens
Lien focuses on converting innovative ideas into practical solutions. With a background in product management and business architecture, she combines various aspects of a solution, from technical architecture to analysis and the development of business models. She plays a connecting role between various stakeholders, in which she brings together technical experts, analysts and domain experts to achieve successful results.
Natasja Bastiaens
GAMP COP Benelux - Chair
Natasja is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.
She`s part of the ISPE GAMP COP Benelux Board since 2018.
