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Employee Competence, Awareness, and Training: Current Trends in Regulatory Compliance and Industry Best Practices

Our Price: $395.00

Product Code: WB-7114

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About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.

Medical device regulators require industry manufacturers to ensure that employees are not only qualified for a given position, but also that the company has provided the necessary job specific training and documentation. One of the biggest challenges faced by manufacturers is demonstrating that employees are fully aware of how the product is used and the impacts that product defects may have on product performance and safety. In order to successfully complete a regulatory inspection, device quality professionals must provide objective evidence and documentation illustrating determined competency and employee evaluations.

  • Methods for exhibiting employee training and competence
  • Comparison of ISO 13485 and FDA QSR requirements and interpretations
  • FDA examination phases and expectations
  • Case study insight and best practices


Thomas Myers
Quality Systems Solutions Director - Global Quality Systems

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Quality Systems
  • Quality Management
  • Training Management

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