Upcoming
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Thursday, January 29, 2026 · 4:00 PM CETDocumentation, Records & Data Governance in Practice
This live webinar focuses on the new EU GMP Chapter 4 draft and its impact on documentation, records, and data governance in GxP environments.
Participants will gain a clear understanding of t... -
Tuesday, February 3, 2026 · 4:00 PM CETFrom draft requirements to practical implementation
The draft revision of EU GMP Annex 11 introduces significant changes that impact how computerized systems are designed, operated, and maintained in regulated GxP environments. This session focus... -
Thursday, February 5, 2026 · 4:00 PM CETFrom regulatory expectations to inspection-ready implementation
The introduction of EU GMP Annex 22 establishes explicit regulatory expectations for the use of artificial intelligence and machine learning (AI/ML) in GxP-regulated environments. Th...
On-demand
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Thursday, December 18, 2025 · 4:00 PM CETValidation is evolving from a document-heavy compliance activity to a thinking-based assurance discipline.
This session explores how FDA’s Computer Software Assurance (CSA) and AI technologies are reshaping CSV, enabling faster, smarter, and more ... -
Thursday, December 4, 2025 · 4:00 PM CETAs organizations move to cloud-hosted and SaaS platforms, traditional validation boundaries blur.
This session examines how to maintain data integrity, traceability, and oversight in cloud-based environments, using the QMS as a control framework r... -
Thursday, November 27, 2025 · 4:00 PM CETArtificial Intelligence and Machine Learning (AI/ML) are transforming data analysis and process optimization across multiple industries. Their impact is already visible in areas such as predictive maintenance, quality monitoring, and operational e...
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Thursday, November 13, 2025 · 4:00 PM CETComputerized systems are central to every GxP process but ensuring they perform reliably and compliantly requires structure and discipline.
This session lays the groundwork: what CSV means, why it exists, and how risk-based approaches ensure trust... -
Thursday, October 16, 2025 · 4:00 PM CESTIn several Data Governance and Data Integrity projects, we have observed a recurring challenge: outsourced processes and systems often remain a blind spot. While organizations focus on cleaning up their internal data, external data from third part... -
Wednesday, September 24, 2025 · 4:00 PM CESTDigitization 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...
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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...
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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SeriesThis three-part live webinar series provides a structured, practical, and risk-based approach to applying the new EU GMP draft requirements of Chapter 4, Annex 11, and Annex 22 in regulated GxP environments.
Designed for QA, QC, IT, CSV, and digi... -
SummitIn an age defined by AI, automation, and cloud technologies, this three-part webinar series revisits the fundamentals of Computer System Validation (CSV) - not to look back, but to strengthen the foundation that enables confident progress.
Each 60... -
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...
