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.
It takes more than teaching simple skills to achieve the state of job readiness and performance required of devicemakers’ workforces. Regulators agree that a comprehensive training program should consider employee education, experience, background and skills. What they don’t agree on is what those concepts mean and how to incorporate them into training.
FDA and ISO Devicemaker Training Requirements breaks down training requirements in both the FDA’s QSR and international standards ISO 13485, 9001 and 10018 — among others — shows where they overlap and where they differ and provides a plan for developing a training program that fills in all the gaps. You will learn:
The four elements of competency
Definitions of key terms and requirements
The concept of a “designated individual” and the qualifications for the role
The importance of a well-written job description
The difference between a “job” and a “role”
Factors in employee awareness and how to foster them
How to evaluate your training program for compliance and effectiveness
Order your copy of FDA and ISO Devicemaker Training Requirements and create a training program that checks all the boxes, both in the U.S. and internationally.
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