(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.

FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.

An FDA Inspection or a Notified Body audit will cover the methods you established to determine competency, evaluate employees, and take actions. All of these activities require objective evidence, in the form of records, to demonstrate your QMS operation.

The webinar helps you understand the requirements and provides methods to build an effective system. The presentation defines and explains the critical competency terms: education, training, skills, and experience. These terms apply to people who affect product conformity. The presenter will use FDA Warning Letters to illustrate many of the issues. This gives you an opportunity to learn from others, so your QMS will not have the same issues.

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:

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

Areas Covered in the Seminar:

Understanding the four dimensions of competency

• Education
• Training
• Background or skill
• Experience

The regulatory requirements

• FDA's QSR (21 CFR §820.25)
• ISO 13485 Clause 6.2.2
• The preamble to QSR
• The QSR Manual
• ISO/TR 14969, the ISO 13485 guidance

Developing the job description

• Including the competency requirements
• Other requirements such a OSHA

Conducting the employee gap analysis

• How to identify gaps
• Documenting you findings

Training

• Identifying training needs
• Using ISO 10015 in a training program
• Determining effectiveness

Special competencies

• People who work on verification or validation
• ISO 14971 requirements
• QSR requirements for a “designated individual”

Who Will Benefit:

This webinar is for people involved in design, production, purchasing, installation, servicing, document control, and human resources for medical device manufacturing.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• HR Managers
• Regulatory Professionals
• Production Managers
• Risk Managers
• Project Managers
• Production Supervisors
• Process Owners
• Quality Audit Managers