Good Clinical Practices (cGCP)

ELM-928 ICH E8 Section 3 – Designing Quality into Clinical Studies

This course unpacks ICH E8, Section 3, also known as Quality by Design (QbD). It explains how QbD helps ensure high-quality clinical trials by emphasizing meticulous planning, risk management, and tailored processes, ultimately leading to safe and effective medications.

CEU Credits: 0.1

Course Code: ELM-928

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: 1.0

Effective Date: 29/04/2024

Curriculum for this course

Welcome

Baking the Perfect Cake

Quality by Design

What Do We Mean When We Say “Quality by Design?”

Key Elements of QbD

What Good QbD Looks Like

Identifying Critical to Quality Attributes (CQA)

Critical to Quality Attributes (CQA)

Establishing a Quality Culture That Supports Open Dialogue

Focusing on Essential Study Activities

Engaging Stakeholders In Study Design

Reviewing Critical to Quality Attributes

Critical to Quality Attributes in Operational Practice

Innovation

Your Turn

Conclusion

Summary

Test Your Knowledge

Author

Nick Cohen

GxP Quality Assurance Expert

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