ISPE GAMP5 2nd edition in Practice
Join us on November 15th, 2023 at the Pivot Park, Oss (NL), for an exciting event on GAMP5 2nd edition and applied use cases, sponsored by Optimum Quality. This event will focus on applying the 2nd edition of GAMP5 in real use cases to inspire you with your future implementations. GAMP(R)5 was updated to the 2nd edition and released in 2022. Learn from experts in the field about how the 2nd edition of GAMP5 can be used to improve quality, efficiency and safety in the pharmaceutical industry:
- ISPE GAMP Global Special Interest Group (SIG) MES has started again
- Presentations on MES
- Agile WMS qualification and implementation
- SAP Validation use case
This meeting will also feature a related Q&A session. Attendees will have the opportunity to ask questions and gain valuable insights from experts on how to apply GAMP(R)5 2nd edition in their situation. Don't miss out on this opportunity to network with industry leaders and gain a deeper understanding of the future of the pharmaceutical industry. Register now on our website and be at the forefront of innovation!
Registration is required for all attendees. A fee of €40 must be paid at registration. ISPE member can access for free.
This event is hosted by Optimum Quality, who is so kind to sponsor the facilities, drinks, and food.
Public transport: you can go here easily by train, station Oss, take 5-10 mins to walk to the Pivot Park.
Car parking: you can park your car at the Pivot Park at a rate of €1,50 per day.
Event Properties
| Event Date | 15-Nov-2023 13.30 |
| Capacity | 67 |
| Registered | 67 |
| Individual Price | €40.00 |
| Location | Pivot Park, Oss (NL) |
Agendas
| 13:30 |
Welcome & Registration. |
| 14:00 |
Welcome - GAMP CoP BeneluxNatasja Bastiaens GAMP COP Benelux |
| 14:05 |
Intro Optimum QualityTim Mojet Optimum Quality Host & Sponsor |
| 15:10 |
Intro Pivot parkPetrik Cuijpers Pivot Sponsor |
| 14:20 |
SIG MES has started againTom de Rudder Member ISPE GAMP Special Interest Group – Manufacturing Execution Systems (MES) |
| 14:35 |
MES Validation in Practice at UCBMathieu Materne UCB |
| 15:10 |
SAP Validation use caseBernard Siebens & Nele Ooms Deloitte / J&J |
| 15:40 |
BreakSponsored by Optimum Quality |
| 16:10 |
Agile WMS validation using digital toolsJan van Rooyen & René van Opstal Imres / Optimum Quality Imres implemented a Warehouse Management System in 3 warehouses in an Agile approach. The validation was managed within DevOps and Modern Requirements. |
| 17:45 |
GAMP5 second edition - from fear for QA to productive cooperatingAksel De Vries MES/Quality advisor GAMP5 second edition has taken the next step from risk-based approach to Critical Thinking. It is devastating for CSV consultants (read: me) as the massive overhead on project quality assurance is now rationalized. I like that. The fear mongering - originating from GAMP4 - is finally replaced by fostering effective cooperation between the shopfloor, process experts, and operational quality. In this presentation we go through CSA success factors, and discuss pitfalls to avoid. |
| 18:20 |
Question & AnswersNatasja Batiaens & Frans Boeijen ISE GAMP COP |
| 18:50 |
Wrap-up & closingISE GAMP COP |
| 19:00 |
Dinner / networkingSponsored by Optimum Quality |
| 20:00 |
Closure |
Speakers
Aksel de Vries
MES/Quality advisor
Aksel works as an independent MES/QA Advisor. His background is Chemical Process Engineering (1996) after which he started as MES Technical Lead in 1998. Recently he obtained a technical MBA (MSc Management of Technology) at TUDelft. Since the early days of 21CFR part11 and Serialization, Aksel has been dedicated to MES in Pharma. He worked in various roles; for Software Vendors, System Integrators, CSV Consultancy Firms, and directly at pharmaceutical projects as MES/QA Advisor for example at BioNTech, Kite Pharma and Amgen Breda.
Tom de Rudder
Member ISPE GAMP Special Interest Group – Manufacturing Execution Systems (MES)
MSc Bio-Engineering (University Ghent) + 20 years working in Pharrma in project & team lead roles, with hands-on project experience in # areas (Manufacturing, QA/QC, IT, Supply Chain, ...) Current role as Manufacturing Systems Lead at Novartis Manufacturing site Puurs, with main focus on IT GxP – CSV, Project Management, Business Process Analysis (Lean/Continuous Imrpovement), SAP, MES, Master Data & Artworks Act as ISPE “volunteer” in GAMP Benelux (board member), GAMP SIG Data Integrity, MES, Pharma 4.0., and as ISPE Belgium Affiliate Board Member.
Jan van Rooyen
IMRES B.V. Project Manager
Supply chain executive with more than 25 years experience in strategy, operations management, project management and business development. Project Manager at Imres B.V. for past two years responsible for managing the implementation of a new warehouse management system (WMS).
Nele Ooms
J&J
Nele Ooms has more than 15 years of experience in various quality and regulatory affairs roles in the pharmaceutical and medical device industry. She started her career at J&J within Janssen R&D QA, where she had different roles and responsibilities over time, ranging from (pre)clinical auditor to finally being responsible for setting up a data driven risk-based audit program for R&D QA. After 13 years, she exchanged the international pharma industry for a start-up, medical device software company, UgenTec. Under her leadership, UgenTec got ISO13485:2016 certified and there AI based software product got FDA approved. Since 2 years Nele rejoined J&J as head of Europe and Africa Technology Quality and Compliance.
Bernard Siebens
Deloitte Belgium
Bernard is a Senior Manager in the IT Risk Consulting team of Deloitte Belgium where he leads the Deloitte ERP validation team across Europe. Bernard is experienced in assessing, governing and testing information systems and related processes. He has performed assessments of IT systems, worked on test management and regulatory compliance. He has performed internal audits and provided support during both internal and external audits. Bernard is a board member of the Belgium Affiliate of the International Society of Pharmaceutical Engineering (ISPE).
Mathieu Materne
UCB
Quality, Compliance and IT Professional with over 20 years of experience in BioPharma industry for international Technical Operations. Strong experiences in GMP/GDP (Engineering, Industrial, Manufacturing, Laboratory and Supply Chain) and Medical Device projects and processes.
Tim Mojet
Optimum Quality
Consultant Partner IT trained CSV expert, with 30+ years of experience as project manager, consultant, and trainer.
René van Opstal
Optimum Quality
René is co-fouder of several ISPE COPs and active in Automation and Computer Validation. He is specialised in using Digital validation by MR4DevOps.
