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Introduction
The latest emphasis from regulatory authorities within clinical study conduct is to design, develop and execute clinical studies using a Quality Management System Approach. While both the FDA and EU emphasize this approach, regulatory agencies provide little direction on how this can be achieved. Risk management is an integral component of a quality system approach. As with a Quality System Approach, many researchers do not have the knowledge, tools or experience to conduct clinical trial risk management.
Regulators have been recommending that a quality system approach be used for the design, develop and execution of clinical studies for the past several years. Many FDA guidances speak on the need to conduct clinical trials using such an approach but provide little in the way of direction in how to accomplish this. This workshop will apply practical approaches and demonstrate associated tools and skills, to assist the participant in using a QMS within the clinical trial arena and assist the participant in identifying and defining the concepts of quality system approach, including the concepts of risk management. This course covers the principles and practical application of a Good Clinical Practice Quality Management System. It covers GCP Risk Management, GCP Root Cause Analysis (RCA), and GCP Corrective and Preventative Actions).
Who Should Attend
- This is designed as an Advanced WS and attendees should have a solid basis and knowledge of Good Clinical Practice, as it applies to the conduct of regulated clinical trials.
Key Takeaways
Meet The Trainer
Lee Truax Bellows is a founder of LTB GCP Consulting, LLC, located In Morris, NY. Lee has an extensive background in pharmaceutical/medical device industries. She has been involved in regulated research for the past 34 years and specializes in GCP Quality Assurance and auditing, SOP development, GCP quality systems consulting, and training on regulated research and Good Clinical Practice.
Lee has earned SQA’s Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP), ACRP’s Certified Clinical Research Associate (CCRA), and IAOCR’s Accredited Qualified Clinical Research Trainer (TIACR) credentials.
