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Ensuring Your Site is Ready for an FDA Inspection

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Wednesday, January 22, 2020  1:00 PM
End:   Wednesday, January 22, 2020  2:30 PM

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Event Features: Business-Related

Neighborhood: Avenue of the Arts


       



http://bit.ly/2ZG8vov


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 site is ready for an FDA inspection
• Inspection preparedness strategy and planning
• Key roles during an inspection

LEARNING OBJECTIVES
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.
WHO WILL BENEFIT
• Quality Engineers
• Compliance Specialists
• Compliance Managers and Directors
• Management Representative
• Quality Managers and Directors
• Business Leaders wishing to present a professional and compliant organization

Use Promo Code XMSNY19 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
http://bit.ly/39xKBA7
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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