Regulatory Affairs & GMP in Biotech

🔍 Overview

This course introduces the fundamentals of regulatory affairs and Good Manufacturing Practice (GMP) for biotechnology products. Participants will learn the basics of EMA and FDA processes, documentation standards, and audit preparation.

Practical examples from clinical trials and product approval pipelines provide real-world context for regulatory compliance.

📘 Modules

• EMA/FDA Basics & Regulatory Timelines
• GMP Documentation & Batch Records
• Clinical Trial Phases & Audit Readiness