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Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Best Practices to Prepare for and Manage EU Notified Bodies Audits and FDA Inspections Webinar
This course will be of great value to medical device professionals involved in regulatory, quality, marketing and other disciplines who provide support for medical devices sold in the USA and in the EU.
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This course will be of great value to medical device professionals involved in regulatory, quality, marketing and other disciplines who provide support for medical devices sold in the USA and in the EU.

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Seminar Summary:

This is a detailed course designed to provide medical device professionals with the information they require to prepare for and manage FDA inspections and Notified Body audits. (see full course description)

 
 
 

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Training Course Syllabus:


Best Practices to Prepare for and Manage EU Notified Bodies Audits and FDA Inspections Webinar

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Vanessa Lopez

Description:

This is a detailed course designed to provide medical device professionals with the information they require to prepare for and manage FDA inspections and Notified Body audits. This course provides the rationale, strategies and flow on how to plan for an inspection/audit, the inspection/audit process and approach, which company roles should be assigned for FDA inspections and Notified Body audits.

Why Should you Attend:

This course is designed to provide participants with an understanding of the purpose of Notified Body audits and FDA Medical Device Inspections. It will furnish details on the following topics:

  • Medical Device Directives and why you need to meet the requirements

  • Why do you need a Notified Body

  • What is a CE mark, its importance and who provides the certification

  • The difference between a Registrar and a Notified Body

  • Types of ISO 13485

  • Significance of ISO 13485 with the Quality Management System (QMS)

  • How does FDA decide on whom to inspect

  • FDA´s enforcements

  • Department of justice settlements

  • QSIT (Devices) Overview

  • How does QSIT relate to the pharmaceutical industry

  • Flow of activities regarding preparation and company roles for a Notified Body Audit and FDA Inspection

  • Inspection/Audit Process: What to Expect From FDA´s or Notified Body´s Arrival up to their exit

  • Timelines to respond to 483s, warning letters and Notified Body´s audit report

  • Format to respond to FDA inspections and Notified Body audits

  • FDA Inspection findings-trends

  • Challenges

  • Conclusions

Objectives of the Presentation:

The course is designed to meet the objectives of:

Preparing for an FDA Inspection and Notified Body audit; the actual flow of company activities and roles; the inspection/audit process, and the impacts of non-compliance to FDA requirements or non-conformity to applicable directive has on the medical devices products, competiveness in the market, revenue, medical device distribution, reliability status, and partnerships with suppliers, among others. It will also provide the challenges and benefits of successful results from an FDA inspection and Notified Body audit.

Seminar Summary:

This is a detailed course designed to provide medical device professionals with the information they require to prepare for and manage FDA inspections and Notified Body audits. (see full course description)

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