Digital Innovation in GMP Environments - Risk without Compliance.
Artificial Intelligence (AI) and modern software automation are rapidly entering regulated pharmaceutical and medtech environments. However, between the current EU GMP Annex 11, the upcoming Annex 22, and the latest ISPE GAMP guidelines, it is becoming increasingly difficult to maintain full oversight. What is actually expected during inspections? What are the critical pitfalls in AI and LLM validation?
This exclusive, half-day live online training cuts through the regulatory noise and prepares you for inspection-ready digital compliance – tailored specifically for QA, IT, CSV, and Regulatory Affairs professionals.
What you will learn in 4 high-impact modules:
• Confidently manage GMP computerised systems under the current Annex 11.
• Understand the revised Annex 11 draft and its upcoming impact on your organisation.
• Apply relevant Best Practices from the ISPE GAMP guidance for system quality.
• Translate the core requirements of the Annex 22 draft into actionable strategies.
• Establish AI models safely and effectively in your regulated daily work.
Your Experts (Live Online):
Learn first-hand from two of Europe's leading experts in GxP compliance and AI governance:
• Oliver
...
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Digital Innovation in GMP Environments - Risk without Compliance.
Artificial Intelligence (AI) and modern software automation are rapidly entering regulated pharmaceutical and medtech environments. However, between the current EU GMP Annex 11, the upcoming Annex 22, and the latest ISPE GAMP guidelines, it is becoming increasingly difficult to maintain full oversight. What is actually expected during inspections? What are the critical pitfalls in AI and LLM validation?
This exclusive, half-day live online training cuts through the regulatory noise and prepares you for inspection-ready digital compliance – tailored specifically for QA, IT, CSV, and Regulatory Affairs professionals.
What you will learn in 4 high-impact modules:
• Confidently manage GMP computerised systems under the current Annex 11.
• Understand the revised Annex 11 draft and its upcoming impact on your organisation.
• Apply relevant Best Practices from the ISPE GAMP guidance for system quality.
• Translate the core requirements of the Annex 22 draft into actionable strategies.
• Establish AI models safely and effectively in your regulated daily work.
Your Experts (Live Online):
Learn first-hand from two of Europe's leading experts in GxP compliance and AI governance:
• Oliver Herrmann (Chair of the ISPE GAMP D-A-CH Steering Committee, Qualified Trainer, >80 executed GxP audits)
• Martin Heitmann (Co-Lead of the ISPE GAMP Guide for Artificial Intelligence, Secretary of the GAMP Global SIG Software Automation & AI)
Included in your Ticket (99 EUR):
• ~4 hours of interactive Live Online Training (1:00 PM - 5:00 PM CET)
• Open Q&A session to discuss your specific organisational challenges
• Official Entourage Certificate of Completion for your training records
• Comprehensive presentation slides as a practical reference guide
*Note: This training will be conducted entirely in English.*
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