GMP Fundamentals Overview Training (EU GMP and 21 CFR 210/211 Comparison)
GMP fundamentals.
2 000 SEK
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Purpose:
Provides a high-level overview of core Good Manufacturing Practice principles, highlighting similarities and key differences between EU GMP requirements and US 21 CFR Parts 210 and 211 to support regulatory awareness.
Regulatory Alignment:
Aligned with EU GMP principles and terminology, with comparative reference to 21 CFR 210/211 for understanding of cross-regional GMP expectations.
Included Files:
• GMP fundamentals overview material
• Comparative summary of EU GMP and 21 CFR 210/211 requirements
• Reference tables highlighting key alignment and divergence areas
Format:
Microsoft PowerPoint or Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, quality assurance teams, regulatory affairs, and operational personnel requiring baseline GMP knowledge across EU and US regulatory frameworks.