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Ensuring Your Site is Ready for an FDA Inspection
Presented By Training Doyens
Wednesday, January 22nd at 1:00pm EST
Online sale ends: 01/22/20 at 1:00pm EST
Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016
26468 E Walker Dr, Aurora, Colorado 80016
Aurora, CO 80016
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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.


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.


•  FDA Inspection approach
•  Ensuring your site is ready for an FDA inspection
•  Inspection preparedness strategy and planning
•  Key roles during an inspection
•  SME (Subject Matter Expert) training
•  FDA audit preparation checklist
•  How to manage an FDA inspection
•  Common mistakes to avoid
•  How to respond to inspection observations


This webinar can help you manage inspections efficiently and effectively.  You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for.  A professional, polished, responsive approach sets a good tone for an inspection.  You will learn how to present information about your quality system in the most competent and professional manner.


•  Quality Engineers
•  Compliance Specialists
•  Compliance Managers and Directors
•  Management Representative
•  Quality Managers and Directors
•  Business Leaders wishing to present a professional and compliant organization
•  Cross-functional leaders wanting to make sure their organizations are well prepared
•  Anyone involved with an FDA or NB inspection


Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Use Promo Code XMSNY19 and get flat 20% discount on all purchases.

To Register (or) for more details please click on this below link:


Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Presented By

1:00pm to 2:30pm
Doors open at 1:00pm

Live Webinar: $159.00
Recorded Webinar: $199.00

Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016<br> 26468 E Walker Dr, Aurora, Colorado 80016<br> Aurora, 80016



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