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Root Cause Analysis: Right the First Time
Under the FDA’s risk-based requirements, every company doing business in the medical products industry, including suppliers, must have a corrective and preventive action (CAPA) program. The most essential component of which is a documented system for discovering the root cause of system failures, nonconformances, product complaints, and inspection findings.
The bottom line is that your root cause analysis should identify why things go wrong…then make sure they don’t happen again.
But the FDA doesn’t teach you how to do this — you’re on your own to figure out the answers to such questions as:
Join industry expert Ronald Schoengold as he provides the answers to those questions and more. He’ll provide you with root cause analysis tools like forms, checklists, and progress charts, along with practical examples to illustrate the process.
In 90 minutes you’ll learn about roles and responsibilities, how to gain management support, and how to prevent 483s, warning letters, and recalls — information which is essential for solving problems and safeguarding your bottom line.
At the end of this presentation you’ll be able to minimize difficulties in fixing problems so that you’ll get it right the first time and to the FDA’s satisfaction. Otherwise you’ll lose time, money and your reputation.
Ronald Schoengold, Certified Regulatory Affairs Professional and Fellow of RAPS
Ronald Schoengold is a consultant to the biotechnology, pharmaceutical and medical device industry. He is a certified regulatory affairs professional and Fellow of the Regulatory Affairs Professional Society. Ron provides advice on quality, regulatory and product development issues, helping businesses effectively commercialize and maintain their products and services. He has been an active contributor to the industry for over 45 years and has developed commercially successful pharmaceutical, screening and diagnostic products for GI medicine, infectious disease and point-of-care testing. Ron is also a principal advisor to the Larta Institute, an NIH supported group that assists young companies who receive SBIR and STTR grants (CAP program). He has published scientific journal articles and presented seminars and webinars on scientific and current regulatory compliance topics. Ron also co-authored a book chapter on point-of-care testing, and holds eight patents related to point-of-care diagnostics. He earned his bachelor’s degree in biology, did his master’s training in microbiology and biochemistry, and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.
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