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

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.

This presentation focuses on devicemakers’ need for an effective system of competence, training, and awareness. Executives in the following roles can especially benefit:

  • Executive suite
  • Human resources
  • Quality executives
  • Regulatory executives
  • Production executives
  • Process owners

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.