(QMS) Competence and Training Requirements per FDA QSR and ISO 13485 2012 is a webinar that covers topics such as:
- State the definitions and the "official" sources
- State the four elements of competency
- Understand the elements of a competence gap analysis
- Describe the contents of a job description
- Identify jobs with special competencies
- Describe the content of a training record and its relationship to competency
- Describe the elements of a training program using the ISO 10015 model
- Understand the concept of a "designated individual" and the qualifications
- Explain how to evaluate and document training effectiveness
(QMS) Competence and Training Requirements per FDA QSR and ISO 13485 2012 brings together Quality Professionals, Quality Managers, Regulatory Professionals, HR Managers, Risk Managers, Production Managers, Production Supervisors, Project Managers, Quality Audit Managers and Process Owners.
