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Environmental Controls for Devicemakers
Environmental controls are a significant issue for medical device manufacturers.
To help you effectively implement environmental controls you must understand their underlying issues. This presentation explains the regulation and uses the regulation’s preamble to help clarify the FDA’s intent. In addition, a warning letter analysis categorizes and describes inspection issues; giving you an opportunity to learn from the mistakes of others.
Join industry expert Dan O’Leary, President of Ombu Enterprises, as he helps you understand environmental controls and shows you how to effectively implement the requirements. Using examples from recent warning letters he analyzes the problems raised and presents solutions you can implement immediately.
In 90 minutes you will learn:
You’ll receive a checklist based on the regulation, warning letters and QSIT to help ensure compliance.
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs. He has a Masters Degree in Mathematics; 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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