Grasp the “why” of Good Manufacturing Practice (GMP) and its impact on your daily work.
This course provides a comprehensive introduction to EU-GMP regulations (Eudralex Vol. 4) and how these requirements influence your day-to-day responsibilities. Through engaging presentations and real-world case studies, you will develop a solid understanding of GMP principles and their application.
This course equips you with the essential knowledge and skills to confidently navigate GMP requirements and apply them effectively in your daily work.
After completing this course, you will:
- Gain a theoretical and practical foundation for understanding and complying with GMP requirements.
- Understand Good Documentation Practice (GDP), including key principles such as Do’s and Don’ts and Right First Time, reinforced through practical exercises.
- Learn about data integrity and the ALCOA principles, with examples illustrating the consequences of non-compliance.
All these insights are designed to help you cultivate the mindset necessary to ensure compliance with GMP standards.
Tailored to Your Needs: This course can be customized to address the unique challenges and focus areas of your organization. For example, it can cover topics such as cross-contamination prevention, risk assessment, or requirements for premises and equipment to ensure medicinal product quality—or any other GMP-related areas most relevant to your needs.
Target group: This course is designed for new operators, technicians , academics, and managers working in production departments or in QA and QC roles.
It’s ideal for those with limited GMP (Good Manufacturing Practice) knowledge who want a comprehensive overview of GMP regulations and practical guidance on implementing them effectively.
The course is also suitable for individuals already working with GMP who wish to deepen their understanding of the rules and the rationale behind them, enhancing their ability to apply GMP principles in their work.