(QMS) Competence and Training Requirements per FDA QSR and ISO 13485

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

Why Should You Attend:

Your Quality Management System (QMS) should be able to address the following questions quickly and easily. If not, then your team needs to attend this webinar!

• Can you list the competency requirements, as an example, for your Management Representative?
• Have you documented the Management Representative's appointment and created records demonstrating the incumbent is competent?
• Can you demonstrate that employees who perform validated processes are aware of the defects and errors they could meet?
• Do your job descriptions include the four elements of competency?
• Can you demonstrate that each employee is competent, based on the job description?
• Can you describe how your company evaluates training effectiveness?

Learning Objectives:

1. State the four elements of competency.
2. State the definitions and the “official” sources.
3. Describe the contents of a job description.
4. Understand the elements of a competence gap analysis.
5. Describe the content of a training record and its relationship to competency.
6. Identify jobs with special competencies.
7. Understand the concept of a “designated individual” and the qualifications.
8. Describe the elements of a training program using the ISO 10015 model.
9. Explain how to evaluate and document training effectiveness.