ICH

ICH Q10 – Management Responsibilities

Based on ICH Q10, this course covers topics of senior management and management responsibilities related to the PQS. Throughout the course learners are given case studies to apply their new knowledge to real-world situations.

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CEU Credits: 0.1
Course Code: ELM-233
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/10/2023

Curriculum for this course

The Story of Europharma DK
Course Introduction
What You'll Learn
Expectations of Management
The Role of Management Responsibilities in GMP
Senior Mangement
Management
Quality Policy
Quality Planning
Company A Case Study Intro
Company A Case Study Conclusion
Resource Management
Internal Communications
Company B Case Study Introduction
Company B Case Study Conclusion
Management Review
Management of Outsourced Activities
Management of Change in Product Ownership
Company C Case Study Introduction
Company C Case Study Conclusion
Europharma DK Conclusion
Conclusion
What We Covered

Test Your Knowledge

Results

Revision History

Author

Joanna Gallant

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