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Digitization is transforming regulated industries, but combining Agile flexibility with GxP compliance remains a challenge. Agile methods enable rapid adaptation and incremental delivery, while GxP predictive approaches provide structure, document...
On-demand
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Thursday, August 21, 2025 · 4:00 PM CESTThe European Union has introduced Annex 22, a landmark regulatory guideline to ensure the safe and GMP-compliant use of Artificial Intelligence (AI) and Machine Learning (ML) in pharmaceutical manufacturing. As the industry embraces digital transf...
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Thursday, August 14, 2025 · 4:00 PM CESTThe long-awaited update to EU-GMP Annex 11 is here - and it’s more than just a refresh. With the draft released in July 2025, this revision reflects the major shifts in digital technology, regulatory expectations, and risk-based compliance.
From ... -
Thursday, August 7, 2025 · 4:00 PM CESTEU-GMP Chapter 4
Documentation has undergone its most significant revision in over a decade, introducing sweeping changes that impact quality systems, data integrity, and compliance practices across the pharmaceutical industry. This expert-led w... -
Thursday, July 10, 2025 · 4:00 PM CESTArtificial Intelligence (AI) and Machine Learning (ML) are transforming pharmaceutical manufacturing - but how can these technologies be safely and effectively implemented in GxP environments?
Join Dr. Ulrich Köllisch and Dr. Jennifer Roebber fro... -
Wednesday, June 11, 2025 · 4:00 PM CESTThis webinar explores regulatory expectations for data retention in GxP environments, with a focus on common pitfalls and enforcement actions. We will review key guidelines, analyze findings from FDA 483s and Warning Letters, and share case studie...
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Thursday, May 22, 2025 · 4:00 PM CESTRegulatory expectations in the pharmaceutical and life sciences industries are constantly evolving. In this session, we’ll help you make sense of current compliance requirements -such as Annex 11 guidelines - and provide a forward-looking perspect...
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Tuesday, February 18, 2025 · 4:00 PM CETIn our experience, audit trails and their reviews are the topics leading to the most and hottest discussions in Data Integrity projects.
This webinar will show you the current best practices:
- What are recent inspection findings on audit trails ... -
Thursday, February 6, 2025 · 4:00 PM CETIn our experience, audit trails and their reviews are the topics leading to the most and hottest discussions in Data Integrity projects.
This webinar will show you the current best practices:
- What are recent inspection findings on audit trails ... -
Monday, May 27, 2024 · 4:00 PM CESTJoin us for a 45-minute webinar on 'From Insights to Impact: The Consultant's Journey at GXP-CC.' We'll explore how consultants turn data into actionable strategies, navigate challenges, and deliver meaningful results. Through case studies and rea...
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Monday, March 11, 2024 · 4:00 PM CETThis webinar provides an overview about inspection trends and latest industry guidelines in 2023 (and beyond).
We will check FDA's inspection database and uncover some recurring inspection topics in 483s and Warning Letters such as Vigilant Monit... -
Thursday, February 29, 2024 · 4:00 PM CETAlmost 2 years after we hosted our first Data Integrity in GCP Webinar, many things have changed with regards to regulatory expectations for the design and conduct of clinical trials while others remain as before. The latest revision to ICH E6 (R3... -
Thursday, November 16, 2023 · 4:00 PM CETICH Q9 established a framework for QRM with the intention of introducing QRM approaches that could be leveraged by both the industry and regulators. However, it has been observed that the full potential of QRM has not been reached, which is the re...
Past
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Tuesday, May 25, 2021 · 4:00 PM CESTRobotic process automation (RPA) software is available to assist Pharma by reducing the time to market, costs in production and improving the management of the compliance requirements, but it also requires a lean and solid validation life cycle to...
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Tuesday, April 27, 2021 · 3:00 PM CESTGet to know about digital transformation with BLOCKCHAIN and learn what to consider in regulatory environments.
Series
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GxP-CC Webinar SeriesJoin our 3-part expert-led webinar series to navigate the most important regulatory changes impacting pharmaceutical compliance in 2025.
With the draft updates to Chapter 4 and Annex 11 - and the groundbreaking release of Annex 22 on Artificial I...
