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