Developing a Competency in Quality Systems for Clinical Research

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“It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” - David Rutledge “Don’t let the place you begin dictate the place you end up” - David Rutledge My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular. David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide. In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience. David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents. Enjoy my interview with David!

• Connect with David Rutledge

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• Six Sigma
• CFDA demonstrates the wisdom of Confucius. He said, “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest.”
• Food and Drug Administration
• Harvard Business Review

• Simple: Conquering the Crisis of Complexity by Alan Siegel and Irene Etzkorn
• Steve Jobs by Walter Isaacson
• Chess Not Checkers: Elevate Your Leadership Game by Mark Miller
• The Art of Asking: How I Learned to Stop Worrying and Let People Help by Amanda Palmer
• Kiss, Bow, Or Shake Hands: The Bestselling Guide to Doing Business in More Than 60 Countries by Terri Morrison and Wayne A. Conaway

• How to pierce through clinical study reports and making insightful comments [09:45]
• About Six Sigma certification [17:05]
• Three basic skills that will make you a better CRO or medical writer [21:59]
• Developing competency in quality systems [31:05]
• Paying for certifications and training [34:40]
• Guidance for productive one-on-one meetings with managers [37:00]
• Learning from the mistakes of others [40:18]
• Keeping current with latest developments in clinical research industry [42:41]
• Working in China and the CFDA [52:20]
• Taking ownership of your career [1:02:45]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.