This foundational course gives your company a shared understanding of GMP fundamentals and how to apply them in daily operations. It builds a strong baseline for new employees or teams transitioning into regulated environments, ensuring they work compliantly and confidently from day one.
Topics covered
• History of GMP: Patient safety, historical context, and the evolution of regulatory frameworks
• GMP Fundamentals: Key principles of GMP in practice and their application in pharmaceutical operations
• Investigations & Change Control: Why deviation handling and change control systems are essential
• GMP Regulations Overview: EU and US requirements impacting pharmaceutical and API manufacturers
• Introduction to Validation: Key concepts in equipment qualification, process validation, and QC method validation
• Good Documentation Practice (GDocP) & Data Integrity: Accurate records and compliance expectations for trustworthy data
• Authority Inspections: What to expect during regulatory audits and how to respond effectively
Course objectives
Your team will learn how to:
• Understand and define key GMP concepts and regulations
• Explain the importance of validation, documentation, and data integrity
• Identify basic regulatory expectations from the EU and US frameworks
• Recognize what to expect from regulatory inspections
• Apply foundational GMP knowledge to ensure compliance and patient safety
Target audience
New employees in regulated environments (QA, production, R&D, QC, supply chain), professionals transitioning into GMP-regulated roles, and service providers working with pharmaceutical manufacturers.
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.