Digitalization is transforming the pharmaceutical industry at breakneck speed. Automated systems, data-driven processes and artificial intelligence are increasingly deployed in GMP-regulated environments, and regulations are evolving accordingly. At the same time, the threat of cybersecurity incidents is increasing, with direct consequences for product quality, patient safety and business continuity.
This one-day training provides you with a complete and current overview of the digital GMP requirements that apply today. We cover the core of Annex 11 for computerized systems, the ALCOA++ principles for data integrity, the new Annex 22 on AI in a GMP context, and the obligations arising from NIS-2 and the EU Cybersecurity Act. In addition to regulations, we also address governance: who is responsible for what, and how do you ensure this within your organization?
The training combines in-depth content with practical applicability. Through workshop scenarios, such as a ransomware attack on a LIMS or the failure of an AI-based batch release system, you practice assessing GMP impact, data integrity risks and the appropriate escalation and reporting procedures. You'll go home with concrete tools that you can apply on the work floor the next day.
This training might be subject to change.
