Overview:
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Why you should Attend:
CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results.
This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years of experience. You will learn about the RCA toolbox and how to get a permanent resolution to your significant quality problems.
Areas Covered in the Session:
Rossana Berardi, MD is a Consultant Medical Oncologist and Lecturer at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology - Università Politecnicadelle Marche - Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs, with a special focus on early phase trials. Dr Berardi is Assistant Professor in Medical Oncology and in Semiotics at Università Politecnica Marche in Ancona and at the Doctorate in Osteoncology, Università "Campus Bio-Medico" in Rome. She is Member and national representative of the Lecturers in Medical Oncology of the Academic Medical Oncology Committee