BEGIN:VCALENDAR
VERSION:2.0
PRODID:Events Booking
BEGIN:VEVENT
UID:6a2d7cc424d2d
SUMMARY:Agile validation in GxP projects
DESCRIPTION:
DTSTART:20191008T113000Z
DTEND:20191008T173000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425065
SUMMARY:Data Integrity Best Practices
DESCRIPTION:
LOCATION:Kloosterstraat\, Oss\, 5349AB North Brabant\, The Netherlands
DTSTART:20200512T113000Z
DTEND:20200512T173000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.76222;5.532839
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Kloosterstraat\, Oss\, 5349
 AB North Brabant\, The Netherlands;X-APPLE-RADIUS=72;X-TITLE=Pivot Park\, 
 Oss (NL):51.76222;5.532839
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4250ad
SUMMARY:VENDOR ASSESSMENT – TRENDS & CHALLENGES - part 1
DESCRIPTION:
DTSTART:20201027T140000Z
DTEND:20201027T153000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4250ce
SUMMARY:VENDOR ASSESSMENT – RISK-BASED APPROACH - part 2
DESCRIPTION:
DTSTART:20201029T140000Z
DTEND:20201029T153000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4250f3
SUMMARY:Computer Software Assurance
DESCRIPTION:
DTSTART:20210330T130000Z
DTEND:20210330T150000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425114
SUMMARY:Paperless Validation
DESCRIPTION:Paperless Validation is a dream for many companies in the Life 
 Science industry. In the current COVID-19 crisis with many travel restrict
 ions\, people have to be creative.. This webinar will show you an example 
 hoe to set a major step forward in realising Paperless Validation by using
  software development tools .
 Experienced consultants in Computer Softwa
 re Validation have created a validation strategy using Microsoft Azure Dev
 Ops and Modern Requirements.
 Participate in this webinar and share your 
 opinion about the applicability of this approach for efficient and Paperle
 ss Validation. More details will follow.
DTSTART:20210518T130000Z
DTEND:20210518T150000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425134
SUMMARY:IT Infrastructure Qualification & Security
DESCRIPTION:
DTSTART:20211014T130000Z
DTEND:20211014T150000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425152
SUMMARY:Critical Thinking & Periodic Review
DESCRIPTION:
DTSTART:20211207T140000Z
DTEND:20211207T160000Z
DTSTAMP:20260613T155236Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425170
SUMMARY:Validation in an Agile environment
DESCRIPTION:
DTSTART:20220330T133000Z
DTEND:20220330T150000Z
DTSTAMP:20220119T053539Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425199
SUMMARY:Data Integrity in New Technologies & launch GAMP 5 2nd edition
DESCRIPTION:
LOCATION:Kloosterstraat\, Oss\, 5349AB North Brabant\, The Netherlands
DTSTART:20221011T113000Z
DTEND:20221011T180000Z
DTSTAMP:20220627T044938Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.76222;5.532839
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Kloosterstraat\, Oss\, 5349
 AB North Brabant\, The Netherlands;X-APPLE-RADIUS=72;X-TITLE=Pivot Park\, 
 Oss (NL):51.76222;5.532839
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4251c6
SUMMARY:Artificial Intelligence supporting Life Science
DESCRIPTION:
LOCATION:Groenenborgerlaan 16\, 2610 Wilrijk\, Belgium
DTSTART:20230419T113000Z
DTEND:20230419T173000Z
DTSTAMP:20230125T095031Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.174068;4.402232
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Groenenborgerlaan 16\, 2610
  Wilrijk\, Belgium;X-APPLE-RADIUS=72;X-TITLE=QbD:51.174068;4.402232
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425200
SUMMARY:ISPE GAMP COP Knowledge Cafe
DESCRIPTION:
DTSTART:20230523T103000Z
DTEND:20230523T113000Z
DTSTAMP:20230509T064521Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42522a
SUMMARY:ISPE GAMP COP Benelux Knowledge Café 
DESCRIPTION:
DTSTART:20231012T103000Z
DTEND:20231012T113000Z
DTSTAMP:20230902T112618Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42525e
SUMMARY:ISPE GAMP5 2nd edition in Practice
DESCRIPTION:Join us on November 15th\, 2023 at the Pivot Park\, Oss (NL)\, 
 for an exciting event on GAMP5 2nd&nbsp\;edition and applied use cases\, s
 ponsored by Optimum Quality. This event will focus on applying the 2nd edi
 tion of GAMP5 in real use cases to inspire you with your future implementa
 tions. GAMP(R)5 was updated to the 2nd edition and released in 2022. Learn
  from experts in the field about how the 2nd&nbsp\;edition of GAMP5 can be
  used to improve quality\, efficiency and safety in the pharmaceutical ind
 ustry:
 
 ISPE GAMP Global Special Interest Group (SIG) MES has started 
 again
 Presentations on MES&nbsp\;
 Agile WMS qualification and implemen
 tation
 SAP Validation use case
 
 This meeting will also feature a rel
 ated 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 ind
 ustry leaders and gain a deeper understanding of the future of the pharmac
 eutical industry. Register now on our website and be at the forefront of i
 nnovation!
 Registration is required for all attendees. A fee of €40 mu
 st 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\, stat
 ion Oss\, take 5-10 mins to walk to the Pivot Park.Car parking: you can pa
 rk your car at the Pivot Park at a rate of €1\,50 per day.
 
LOCATION:Kloosterstraat\, Oss\, 5349AB North Brabant\, The Netherlands
DTSTART:20231115T123000Z
DTEND:20231115T190000Z
DTSTAMP:20230822T171750Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.76222;5.532839
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Kloosterstraat\, Oss\, 5349
 AB North Brabant\, The Netherlands;X-APPLE-RADIUS=72;X-TITLE=Pivot Park\, 
 Oss (NL):51.76222;5.532839
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4252a2
SUMMARY:GAMP Knowledge Café - Future of MES
DESCRIPTION:On the 12th of December 2023 at 12:30 GAMP COP Benelux will org
 anize its 3rd knowledge cafe. This is Q&A discussion forum related to the 
 future of Manufacturing Execution Systems (MES). This is a 1-hour session 
 where you can discuss with peers what you think about the future of MES.

  
 In what way will AI influence the future of MES systems?
 What would 
 be beneficial in the future MES systems?
 How can we use MES systems to g
 enerate e-logbooks?
 ...
 
 We are happy that Subject Matter Expert fro
 m (bio-)pharma companies will join us in the discussion.
 As seats are li
 mited\, make sure you register asap.
DTSTART:20231212T113000Z
DTEND:20231212T123000Z
DTSTAMP:20231123T050018Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4252cf
SUMMARY:Applying GAMP5 to AI/ML based systems
DESCRIPTION:
DTSTART:20240222T113000Z
DTEND:20240222T123000Z
DTSTAMP:20240122T082836Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4252fd
SUMMARY:Computerized systems and electronic data in clinical trials
DESCRIPTION:
LOCATION:Allée de la Recherche - Researchdreef\, Anderlecht\, 1070 Brussel
 s-Capital\, Belgium
DTSTART:20240529T113000Z
DTEND:20240529T173000Z
DTSTAMP:20240405T122018Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:50.81768;4.275722
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Allée de la Recherche - Re
 searchdreef\, Anderlecht\, 1070 Brussels-Capital\, Belgium;X-APPLE-RADIUS=
 72;X-TITLE=UCB:50.81768;4.275722
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425327
SUMMARY:ISPE GAMP COP BENELUX KNOWLEDGE CAFE
DESCRIPTION:
DTSTART:20240703T103000Z
DTEND:20240703T113000Z
DTSTAMP:20240620T103828Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425353
SUMMARY:Going digital in manufacturing & laboratory operations
DESCRIPTION:
LOCATION:Franklinweg 7\, Gorinchem\, 4207HX\, Netherlands
DTSTART:20241112T130000Z
DTEND:20241112T190000Z
DTSTAMP:20240911T124915Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.841795;5.00772
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Franklinweg 7\, Gorinchem\,
  4207HX\, Netherlands;X-APPLE-RADIUS=72;X-TITLE=Van der Valk Hotel Gorinch
 em:51.841795;5.00772
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42537e
SUMMARY:Agile Validation in a GxP environment
DESCRIPTION:
DTSTART:20250423T103000Z
DTEND:20250423T113000Z
DTSTAMP:20250401T151313Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4253a7
SUMMARY:Different perspectives on SAAS Validation
DESCRIPTION:
LOCATION:Allée de la Recherche - Researchdreef\, Anderlecht\, 1070 Brussel
 s-Capital\, Belgium
DTSTART:20250619T120000Z
DTEND:20250619T180000Z
DTSTAMP:20250505T153324Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:50.81768;4.275722
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Allée de la Recherche - Re
 searchdreef\, Anderlecht\, 1070 Brussels-Capital\, Belgium;X-APPLE-RADIUS=
 72;X-TITLE=UCB:50.81768;4.275722
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4253db
SUMMARY:AI Data & Model Governance Management
DESCRIPTION:AI Data & Model Governance Management\, with Sam Laermans (NNIT
  - AI Director) as keynote speaker
 Are you ready for AI in Computerized 
 Systems ? Discover the Power of AI Governance at the Knowledge Café!
 Wh
 at can we learn from&nbsp\;new GAMP Guide: Artificial Intelligence&nbsp\;a
 nd&nbsp\;Annex 22 (draft)&nbsp\;about&nbsp\;AI data and model governance m
 anagement&nbsp\;transforming your computerized systems into AI-enabled com
 puterized systems?
 Join us at next GAMP CoP Benelux Knowledge Café
 

  Date: 01 December 2025
 Time: 12:30-13:30 CET
 Format: Keynote speaker 
 + interactive Q&A & discussion
 
 Register now (free of charge) and join
  your peers in exploring the future of Artificial Intelligence.&nbsp\;
 A
  Microsoft Teams invite will be send about 1 day before the event to all r
 egistered persons.
 The Knowledge Café will include a Q&A session\, plea
 se enter your question(s) during the registration or via MS Teams Chat dur
 ing the call.
DTSTART:20251201T113000Z
DTEND:20251201T123000Z
DTSTAMP:20251029T194027Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42540b
SUMMARY:How to survive an inspection?
DESCRIPTION:Join us on the 12th of December 2025 at KEMBIT in Eindhoven (NL
 ) for an insightful Gamp Benelux COP event on “Inspection Readiness of C
 omputerized Systems.”
 This event will provide you with practical appro
 aches\, discussions and real-world examples on how to ensure that your com
 puterized systems are ready for regulatory inspections. Learn from experie
 nced professionals how to prepare your teams\, processes\, and infrastruct
 ure to confidently face inspection scenarios.
 Our speakers will share th
 eir expertise on:
 
 Lessons learned and practical guidance from real in
 spection experiences
 Ensuring a compliant\, secure\, and inspection-read
 y IT landscape
 
 Attendees will have the opportunity to engage with exp
 erts\, ask questions\, and gain valuable insights into how leading organiz
 ations achieve and maintain inspection readiness.
 Don’t miss this oppo
 rtunity to network with industry peers and deepen your understanding of re
 gulatory expectations and best practices for computerized systems. Registe
 r now on our website and make sure your organization is inspection-ready!

 
 The event starts at 09h30 and ends at 16h00.
 Location:&nbsp\;Conferenc
 e Centre in De StripHigh Tech Campus\,5656 AE Eindhoven\,The Netherlands

  The event is open for both ISPE members (free of charge) and non-ISPE mem
 bers (€40). Registration is required.
LOCATION:High Tech Campus\, Eindhoven\, 5656AE North Brabant\, Netherlands
DTSTART:20251212T090000Z
DTEND:20251212T140000Z
DTSTAMP:20250924T122923Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.410905;5.459671
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=High Tech Campus\, Eindhove
 n\, 5656AE North Brabant\, Netherlands;X-APPLE-RADIUS=72;X-TITLE=Conferenc
 e Centre in De Strip:51.410905;5.459671
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42543b
SUMMARY:How to survive an inspection? (2)
DESCRIPTION:Join us on the 12th of December 2025 at KEMBIT in Eindhoven (NL
 ) for an insightful Gamp Benelux COP event on “Inspection Readiness of C
 omputerized Systems.”
 This event will provide you with practical appro
 aches\, discussions and real-world examples on how to ensure that your com
 puterized systems are ready for regulatory inspections. Learn from experie
 nced professionals how to prepare your teams\, processes\, and infrastruct
 ure to confidently face inspection scenarios.
 Our speakers will share th
 eir expertise on:
 
 Lessons learned and practical guidance from real in
 spection experiences
 Ensuring a compliant\, secure\, and inspection-read
 y IT landscape
 
 Attendees will have the opportunity to engage with exp
 erts\, ask questions\, and gain valuable insights into how leading organiz
 ations achieve and maintain inspection readiness.
 Don’t miss this oppo
 rtunity to network with industry peers and deepen your understanding of re
 gulatory expectations and best practices for computerized systems. Registe
 r now on our website and make sure your organization is inspection-ready!

 
 The event starts at 09h30 and ends at 16h00.
 Location:&nbsp\;Conferenc
 e Centre in De StripHigh Tech Campus\,5656 AE Eindhoven\,The Netherlands

  The event is open for both ISPE members (free of charge) and non-ISPE mem
 bers (€40). Registration is required.
LOCATION:High Tech Campus\, Eindhoven\, 5656AE North Brabant\, Netherlands
DTSTART:20251212T090000Z
DTEND:20251212T140000Z
DTSTAMP:20260420T175135Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.410905;5.459671
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=High Tech Campus\, Eindhove
 n\, 5656AE North Brabant\, Netherlands;X-APPLE-RADIUS=72;X-TITLE=Conferenc
 e Centre in De Strip:51.410905;5.459671
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc425469
SUMMARY:Knowledge Café - AI & Evolution of System Validation in the Health
 care Sector
DESCRIPTION:AI & Evolution of System Validation in the Healthcare Sector\, 
 with&nbsp\;Giovanni Orlando (CSV/CSA & Data Integrity Expert and Associate
  Partner PQE Group) as keynote speaker
 As traditional validation approac
 hes struggle with AI's dynamic nature\, global&nbsp\; regulators (FDA\, EM
 A) are updating compliance frameworks to address AI-specific risks. Ensuri
 ng explainability and bias mitigation is key to maintaining data integrity
 . Ultimately\, AI is reshaping system validation\, requiring a new paradig
 m for compliance in a digital pharma future.
 Join us at next GAMP CoP Be
 nelux Knowledge Café
 
 Date: 11 Maart 2026
 Time: 12:30-13:30 CET
 F
 ormat: Keynote speaker + interactive Q&A & discussion
 
 Register now (f
 ree of charge) and join your peers in exploring the future of Artificial I
 ntelligence.&nbsp\;
 A Microsoft Teams invite will be send about 1 day be
 fore the event to all registered persons.
 The Knowledge Café will inclu
 de a Q&A session\, please enter your question(s) during the registration o
 r via MS Teams Chat during the call.
DTSTART:20260311T113000Z
DTEND:20260311T123000Z
DTSTAMP:20260205T182653Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc42549a
SUMMARY:Adopting data-driven solutions and AI technologies within the real
 m of industrial automation
DESCRIPTION:Adopting data-driven solutions&nbsp\;and AI technologies within
  the realm of industrial automation
 Learn about journey in adopting data
 -driven solutions and AI technologies within the realm of industrial autom
 ation: from complete ignorance to converting factory in testing ground for
  modern technologies\; from pioneering the first AI Controller in 2017 to 
 developing data-driven solutions and virtual twins by 2025.&nbsp\;
 
 Da
 te: 29 April 2026
 Time: 12h30-13h30 CET
 Format: Keynote speaker + inte
 ractive Q&A & discussion
 
 Register now (free of charge) and join your 
 peers in exploring the future of Artificial Intelligence.&nbsp\;
 A Micro
 soft Teams invite will be send about 1 day before the event to all registe
 red persons.
 The Knowledge Café will include a Q&A session\, please ent
 er your question(s) during the registration or via MS Teams Chat during th
 e call.
DTSTART:20260429T103000Z
DTEND:20260429T113000Z
DTSTAMP:20260225T204239Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
BEGIN:VEVENT
UID:6a2d7cc4254c7
SUMMARY:GenAI in life science
DESCRIPTION:Explore the realistic applications of AI\, significant reduced 
 manual workload and lead times while minimizing errors.
 Delaware enginee
 red an automated content‑labelling solution for a global pharmaceutical 
 company facing high costs and long lead times in tagging brand‑specific 
 marketing content. The solution architecture combined Azure Databricks\, M
 Lflow\, Azure OpenAI\, and other Azure AI services to process and interpre
 t diverse document types and generate accurate labels.
 
 Date: 17 June 
 2026
 Time: 12h30-13h30 CET
 Format: Keynote speaker + interactive Q&A &
  discussion
 
 Register now (free of charge) and join your peers in expl
 oring the future of Artificial Intelligence.&nbsp\;
 A Microsoft Teams in
 vite will be send about 1 day before the event to all registered persons.

 
 The Knowledge Café will include a Q&A session\, please enter your quest
 ion(s) during the registration or via MS Teams Chat during the call.
DTSTART:20260617T103000Z
DTEND:20260617T113000Z
DTSTAMP:20260223T153519Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
END:VEVENT
END:VCALENDAR