Training Doyens

OVERVIEW Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection. WHY SHOULD YOU ATTEND An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar. AREAS COVERED •  FDA Inspection approach •  Ensuring your sit...

OVERVIEW Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection. WHY SHOULD YOU ATTEND An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar. AREAS COVERED •  FDA Inspection approach •  Ensuring your sit...