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!
Areas Covered in the Seminar:
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:
Dan, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Medical Device regulations require that manufacturers have enough people to perform all of the required tasks and that everybody is competent to do her job. The regulations also require the four dimensions of competency: education, training, background or skill, and experience.
As a medical device manufacturer, you must define the requirements for each job, evaluate the people in those jobs, develop a gap analysis for each person, and create a plan to close those gaps.
This webinar explains the competency dimensions, using the formal definitions. Many companies find confusion among these four dimensions. In addition to the formal definitions, the webinar explains the differences and illustrates them with examples.
While all four dimensions are equally important, the regulations place special emphasis on training. The manufacturer typically has the greatest control of training, especially related to the company’s policies, processes, procedures, and work instructions. As a result, ISO 13485 requires an effectiveness evaluation of training or other actions to satisfy competency requirements.
This webinar provides the information you need to assure your system is effective and complies with the regulation.
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