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Clinical Trial Optimization Podcast

The Evolving Role of the QA Professional with David Fryrear and WCG Senior Advisor Linda Sullivan


What’s the best way develop world-class Quality Assurance (QA)  professionals in the clinical trials industry? That’s one the key questions explored during Linda Sullivan’s interview with David Fryrear, Executive Vice President and Head of Quality Assurance at Astellas Pharma, Inc. Clinical QA was first defined as “auditing,” says Fryrear, but it has morphed into a critical element in Quality Management Systems and is continuing to transform itself today. In addition, Fryrear notes, QA is now a resource for business partners and is a key contributor and independent voice in critical decision-making in the clinical trials process. Today, Fryrear says, top-notch QA professionals must demonstrate an ability to go beyond simply being well versed in regulatory and compliance issues, but must have different competencies, including an understanding of risk management, the ability to interpret data and apply critical thinking to solve problems as well as communicate effectively with peers and business partners. Fryrear notes that Astellas has mapped out the core competencies needed and provides employees with opportunities to work closely with experienced staff to learn about and broaden their knowledge and expertise. “Quality is not the responsibility of QA – it is something that everyone needs to get involved in,” says Sullivan.

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