Stay ahead of evolving regulations and authority expectations with this advanced company training. Your teams will get up to speed on the latest developments, trends, and focus areas within GMP — ensuring your quality systems and inspection readiness strategies are fully aligned with what regulators expect right now.
Topics covered
• EU regulatory updates: Non-compliance report statistics, Annex 11 and 22 draft (data integrity, computerized systems & AI), News on the EU legislation overhaul
• FDA trends: Top 483 citations and warning letters, validation enforcement, Remote regulatory Assessments and the QMM program, USP 1079
• ICH & PIC/S news: Analytical lifecycle (ICH Q14) and global harmonization initiatives
Course objectives
Your team will learn how to:
• Get up to speed with current GMP regulations (EU/FDA/ICH/PIC/S)
• Understand what authorities are focusing on now
• Identify trends that may impact inspections and QMS
• Strengthen compliance strategies for 2025 and beyond
Target audience
GMP professionals in QA, QC, Regulatory Affairs, Manufacturing, Validation, and Inspection Readiness.
At Epista, our trainers are recognized industry specialists with decades of experience in compliance, auditing, and inspection readiness. They combine deep regulatory knowledge with practical expertise to empower your teams to operate with confidence and pass inspections seamlessly.
We offer training in English, Danish, and Swedish.
Get in Touch
If you want to explore how these trainings and services can support your company, reach out to us, and let’s discuss a tailored plan designed for your organization.