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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 QMS Approach. Risk Management (RM), Root Cause Analysis (RCA) and Corrective and Preventative Actions (CAPA) are all integral components of a quality management system approach. Many researchers do not have the knowledge, tools or experience to conduct clinical trial risk management and this course is designed to meet that need.
Regulators have been recommending that a QMS 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 practical 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 GCP arena and assist the participant in identifying and defining the concepts of a QMS This course covers the principles and practical application of a GCP QMS. It covers RM, RCA, and CAPA.
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
The attendee will be able to :
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.
