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Home » Store » Webinar Recordings » Meeting the Competence, Training and Awareness Rules for Medical Device Manufacturers - Webinar Recording/Transcript

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Meeting the Competence, Training and Awareness Rules for Medical Device Manufacturers - Webinar Recording/Transcript

$287.00
Webinar Recordings

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Meeting the Competence, Training and Awareness Rules for Medical Device Manufacturers

Device manufacture is a complicated business, but few areas are more rulebound than QMS. Many a devicemaker has come up short trying to stay abreast of the FDA’s QSR, ISO 13485:2016, and other ISOs while trying to comply with competence, training and awareness rules.

Don’t risk regulatory hassles that can hamper profitability. Sign up now for a back-to-basics presentation that equips you with compliance tools and techniques you’ve been searching for.

Your presenter is Dan O’Leary, FDAnews’s go-to specialist on device quality compliance. Starting with the basics, he’ll translate regulatory gobbledygook into the language you speak every day: plain English. You’ll discover:

  • The four elements of competency and how to include them in job descriptions
  • The concept and qualifications of a ‘designated individual’
  • Secrets of a well-written job description
  • Implementing the competence acquisition process: Using the ISO 10018:2012 model
  • Implementing a training program: Using the ISO 10015:1999 model
  • Competence gap analysis, and how to close identified gaps
  • Evaluating and documenting training effectiveness
  • Ensuring employee awareness: A how-to
  • And much more!

Failure to understand what is required triggers a risk of audit findings. Get the compliance tools and techniques you need.

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