This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
Quality Risk Management (QRM) is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
Environmental Monitoring (EM) is a critical component to ensuring microbial contamination control in pharmaceutical product development, research, and manufacturing settings. Using a risk-based approach to EM can save money while improving efficiencies and product quality. This webinar will show you how.
In this course you will learn the vital connection between the documentation and training spheres, including how they interact and why communication between document writers and trainers is so important.
This course will enable you to have and understanding of how to construct a Quality Manual while avoiding common pitfalls and ensuring regulatory compliance.
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
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