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Statistical Concepts of Process Validation
Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016.
But compliance is only half the story. Failure in process validation leads to liability and lawsuits, while excellence in product validation leads ultimately to greater profits.
It’s time to brush up your process validation procedures and the perfect coach is Dan O’Leary, FDAnews’s go-to guy on technical training for devicemakers.
Process validation is a process, one calling for patience and precision, training and retraining. Grab this opportunity for 90 minutes of training (or retraining) with the best in the business.
Dan O’Leary, one of FDAnews’s most sought-after presenters, is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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