Webinars > All COMPLIANCE Categories > Compliance Courses Webinars Practical Training & Employee Competency Management WebinarBy following the principles outlined in this webinar, you will be able to minimize the risk of your submission being rejected and will increase the potential for a speedy review and approval by the FDA. You will learn what the FDA expects for a 510K submission. Course Description/AgendaPractical Training & Employee Competency Management Overview:
Training management is often focused only on aligning standard operating procedures with job titles, and tracking whether employees have been "trained" to the latest versions. But, quality standards and regulations actually focus on employee competence and awareness of their impact on quality. This webinar will help attendees to better understand the actual intent of the standards and regulations, how to better establish requirements for each employee, and how to confirm that employees are truly competent. .
Who Will Benefit:
Steve Gompertz is a leader in Quality Systems management with over 25 years' 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. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality. 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.
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