File Name: | Good Manufactoring Practices (GMP) Mastery |
Content Source: | https://www.udemy.com/course/good-manufactoring-practices-gmp-mastery/ |
Genre / Category: | Other Tutorials |
File Size : | 2 GB |
Publisher: | udemy |
Updated and Published: | May 22, 2025 |
What you’ll learn
- Interpret global GMP regulations and standards to ensure manufacturing compliance with FDA, EMA, WHO, and PIC/S guidelines.
- Develop and implement a Quality Management System (QMS), including document control, policies, roles, and continuous improvement processes.
- Apply Quality Risk Management (ICH Q9) by conducting risk assessments and implementing mitigation strategies across product lifecycles.
- Design and validate cleaning, sanitation, and change control procedures to maintain contamination control and facility hygiene.
Dive deep into the core principles of Good Manufacturing Practice (GMP) and establish a robust Quality Assurance (QA) foundation for your organization. This comprehensive, hands-on course will guide you through global regulatory frameworks, Quality Management Systems (QMS), essential operational elements, and strategies for continuous improvement.You’ll start by understanding the origins and purpose of GMP, exploring key regulations from FDA, EMA, WHO, and PIC/S. Next, you’ll learn how to design and implement a comprehensive QMS that includes document control, organizational roles, standard operating procedures (SOPs), and process oversight.
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