Biomedical manufacturers and their suppliers rely on an effective quality management system to ensure they produce safe and effective products, and comply with numerous regulatory requirements. Despite the critical importance of the quality management system, many of those working for these types of companies have had little or no formal training.
This class fills that gap by explaining what a quality system is and what it’s real intent is, the history of the regulations that define the requirements, what those requirements are, and what they really mean. This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system. Those who have been in the industry for a long time in many roles may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system.
When: Thursday, February 8, 2018, 8:00 am – 4:30 PM
Cost: -Minnesota ASQ Member – $225 Breakfast, lunch and handouts are included.
-ASQ Enterprise Member- $225
-Non-Member – $250
About Our Presenter
Steve Gompertz is a leader in Quality Systems management with over 20 years of experience in the life-science industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University’s Master of Science in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.