(QMS) Competence and Training Requirements per FDA QSR and ISO 13485 (Medical Devices)
Venue: Online Event
|Event Date/Time: Aug 29, 2012||End Date/Time: Aug 29, 2012|
FDA QSR states, â€œEach 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.â€ The corresponding requirement in ISO 13485 and ISO 9001, says, â€œPersonnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experienceâ€.
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.