ICH Quality Guidelines: Intent and Overview

Consider what it takes to create a safe, effective, high quality pharmaceutical product that complies with global International Conference on Harmonization (ICH) Quality Guidelines. In this course, students review each guideline pertinent to drug development, patient safety, health authority review, and commercial manufacturing. This uniquely robust overview provides an understanding of the regulatory intent, helping to prepare professionals for competitive job roles in San Francisco Bay Area biopharma. While primarily aimed at R&D, manufacturing, quality control, quality assurance and CMC-regulatory professionals, the course is useful for anyone who wants to understand harmonized quality guidelines and development strategies.

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