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SUMMARY:Quality CoP Kick-Off Webinar: Advancing Quality Thinking
DESCRIPTION:Quality CoP Kick-Off Webinar: Advancing Quality Thinking
 We a
 re proud to officially launch the ISPE NL Quality Communitv of Practice - 
 a new forum for life sciences professionals to strengthen knowledge\, conn
 ect expertise\, and collaborate on the future of pharmaceutical quality.

  
 
 To mark this milestone\, we invite you to our first community event
 .
 Date: 21 Januarv 2026
 Time: 12:00-13:00 CET
 Speaker: Astrid Bulsin
 k
 Format: webinar
 Advancing Quality Thinking: The New Focus on Risk Ma
 nagement\, Data Integrity & Process Understanding
 Recent proposed update
 s to Eudralex Volume 4 - ncluding Chapter 1\, Chapter 4\, Annex 11 and the
  ntroduction of Annex 22 on Artificial Intelliaence - reflect a rapidly ev
 olving GxP landscape driven by automation\, digitalisation and data integr
 ity needs.
 As technology accelerates\, quality professionals must not on
 ly comply - but think\, interpret and lead.
 In this session\, we will ex
 plore:
 - What links the current regulatory revisions
 - Why QRM is more
  than identifying risks
 - How expected Data Integrity maturity is changi
 nc
 - The growing need for product & process understanding
 Why knowledg
 e management and culture matter The role of senior leadership in next-gene
 ration Quality systems.
 This webinar marks the beginning of many activit
 ies from the new CoP - a community dedicated ta pioneering Quality thinkin
 g in the Netherlands and beyond\, together with DARQA and NIA - Vereniging
  var Nederlandse Industrie-Apothekers
 Register here:&nbsp\;https://ispe-
 events.us3.list-manage.com/track/click?u=f8430f240063bbae2d9a89ecd&id=931a
 59ab20&e=72d7f6ac39
 
 Acknowledgement to QbD Group for technical suppor
 t of this webinar.
 We look forward to seeing you at the launch - and to 
 building this strong Quality network with you.
LOCATION:https://global.gotomeeting.com/join/673536741
DTSTART:20260121T110000Z
DTEND:20260121T120000Z
DTSTAMP:20260114T071515Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
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BEGIN:VEVENT
UID:6ab1b160de60f
SUMMARY:Good Working Practices (GWP). Without Silos: Quality\, Culture & In
 tegration
DESCRIPTION:
LOCATION:Sylviusweg 70\, 2333 Leiden\, Nederland
DTSTART:20260609T100000Z
DTEND:20260609T170000Z
DTSTAMP:20260322T132221Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:52.168812;4.467931
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Sylviusweg 70\, 2333 Leiden
 \, Nederland;X-APPLE-RADIUS=72;X-TITLE=Biotech Training Facility :52.16881
 2;4.467931
END:VEVENT
BEGIN:VEVENT
UID:6ab1b160de658
SUMMARY:Engineering Quality: A Journey Through URS and Risk Management
DESCRIPTION:URS & Risk Assessment: The Foundation for Successful Engineerin
 g
 A well-defined User Requirements Specification (URS) and a thorough Ri
 sk Assessment form the foundation of successful projects within the pharma
 ceutical industry. But how can you ensure that requirements\, engineering\
 , and quality are aligned from the very beginning?
 During this event\, o
 rganised as a collaboration between the CQV Community of Practice and the 
 Quality Community of Practice of ISPE\, we will explore the connection bet
 ween engineering\, quality\, and risk management.
 The event will focus o
 n the practical application of developing an effective URS and performing 
 risk assessments within pharmaceutical projects. We will discuss how a ris
 k-based approach can support better decision-making\, create clearer requi
 rements\, and contribute to more efficient engineering and quality process
 es.
 This event is aimed at professionals at all levels working in the ph
 armaceutical industry who have an interest in engineering\, quality\, comm
 issioning & qualification\, validation\, and risk assessments. It provides
  an excellent opportunity to exchange knowledge and experiences and to bri
 ng together different perspectives from both engineering and quality.
 Jo
 in us for an inspiring and interactive event where practical experience\, 
 knowledge sharing\, and collaboration take centre stage.
LOCATION:Beerse\, 2340 Antwerp\, Belgium
DTSTART:20261026T120000Z
DTEND:20261026T160000Z
DTSTAMP:20260903T103555Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
GEO:51.311955;4.867799
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Beerse\, 2340 Antwerp\, Bel
 gium;X-APPLE-RADIUS=72;X-TITLE=JNJ Beerse:51.311955;4.867799
END:VEVENT
BEGIN:VEVENT
UID:6ab1b160de69f
SUMMARY:AI in GxP Auditing: From Hype to Validated Practice
DESCRIPTION:Discover how AI is already supporting real-world GxP auditing
 —from document review and finding classification to report drafting—wh
 ile maintaining regulatory compliance and human oversight. The session wil
 l include practical insights\, a live demonstration\, and an interactive d
 iscussion on responsible AI adoption in Quality.&nbsp\;
DTSTART:20261030T110000Z
DTEND:20261030T121500Z
DTSTAMP:20260914T144143Z
ORGANIZER;CN=ISPE NL:MAILTO:opstalr
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