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
Participants 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
This course is ideal for:
- New employees in regulated environments (QA, production, R\&D, QC, supply chain, etc.)
- Professionals transitioning into GMP-regulated roles
- Anyone seeking to refresh and formalize their understanding of GMP basics
- Service providers working with pharmaceutical manufacturers
Meet your instructor
Per H. Damgaard
Dr. Per H. Damgaard is Vice President for Training, Education & Audit at Epista.
Led by oneof the industry’s most respected voices in compliance, Dr. Per H. Damgaardbrings decades of experience in GMP training, regulatory inspections, andquality assurance across the life science industry.
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