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Compliance 4 All
Compliance 4 All presents

Virtual Classroom (Live) Practical Training & Employee Competency Management Webinar

By 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/Agenda


Practical 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. 



Why should you Attend:

  • Does your quality management system treat training as automatically leading to competency?
  • Are employee training and competency requirements aligned with their job titles or the role(s) they perform?
  • Does training focus on how to perform work and what results are required?
  • Are temporary employees trained the same as regular employees?
  • Do your quality metrics take a hit whenever new or temporary employees are engaged?
  • Do you treat post-training quizzes as demonstration of competency?



Areas Covered in the Session:

  • What are the differences between competency and training, and how are they connected?
  • How should requirements be established for each employee's specific role(s)?
  • What should training cover?
  • How should temporary employee competence be addressed?
  • How can companies truly demonstrate employee competency?
  • How can all of this be managed effectively and efficiently?

  • Who Will Benefit:

      • Quality Manager
      • Quality Director
      • Quality Systems Specialist
      • Quality Engineer
      • Regulatory Affairs Manager
      • Regulatory Affairs Director
      • Regulatory Affairs Specialist

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.

 

More Webinar Information

Compliance 4 All
Compliance 4 All

Course Summary

By 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.

Delivery Method

Virtual Classroom (Live) Virtual Classroom (Live)

Who Should Attend

• Quality Manager • Quality Director • Quality Systems Specialist • Quality Engineer • Regulatory Affairs Manager • Regulatory Affairs Director • Regulatory Affairs Specialist

 
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Virtual Classroom (Live)

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