This webinar will provide direction on a practical approach to incorporating a quality system approach it into the practice of their daily clinical research activities. The session is geared towards intermediate participants at both the site and sponsor level who already have a good understanding in the requirements of clinical research but are seeking further direction in how to execute research from a quality systems approach.
Why should you Attend :
Clinical studies continue to fail to meet the minimum regulatory requirements as evidence by regulatory citations that are issued on a fairly consistent basis. What is even more concerning is that these areas of concern remain the same year after year and include inadequacy in; study oversight, protocol compliance, investigational product accountability, training, and IRB/IEC oversight. With all the emphasis on training that many sponsors and investigators put their staff through, the guidance documents issued by the regulatory authorities, continued negative inspections and resulting citations, which in turn result in negative publicity, why does this continue to happen in this day and age? Applying a quality system approach based on risk management will help ensure that industry and their partners, such as third party vendors and site personnel, are better prepared to identify and plan for potential risk areas, plus deal with issues as they arise.
Areas Covered in the Session:
- We will review the key definitions of a quality system approach and risk management
- Provide tips on how to identify risk within a clinical study and discuss how to manage it
- Provide an overview of contingency plans and corrective actions that are utilized once an issue has been identified.
Who will benefit:
Clinical Research managers
Clinical Research Associates
Quality Assurance Professionals
Lee Truax-Bellows has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Regulatory Consultant Monitor, Medical Communications Associate, Senior Quality Auditor, Senior Trainer and Project Manager. Lee has been involved in regulated research for over 20 plus years and specializes in product development, GCP auditing, and training on regulated research and Good Clinical Practice.
Lee is a founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a clinical contract research organization (CRO) based in upstate NY. NCRA has been providing clinical research expertise in medical device, pharmaceutical, and nutraceutical development since 1994. NCRA provides full service CRO services such as monitoring, auditing, technical writing, data management, biometrics and product development consulting.
Lee is active in the Association of Clinical Research Professionals (ACRP) and Society of Quality Assurance (SQA).
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