Start Date:4/4/2017

Start Time:2:00 PM EDT

Duration:45 minutes

Abstract:

For medical device manufacturers, surviving an audit can be nerve-racking. In the back of your mind, you know the stories of how companies on the FDA watch list frighten away potential customers and investors. But even for an established medical device company, the audit process can still be scary.

 

On Tuesday, April 4, join Apical Instruments’ Director of Regulatory Affairs/Quality Assurance Kim Khoe and Arena Solutions’ Director of Compliance Yelena Bolton for a webinar that will walk you through a step-by-step real world example on how to pass an audit exam with flying colors. 

 

In this webinar, you’ll learn:

 

  • How to show the auditor you do what you say 
  • How Arena helps medical device companies with FDA compliance and audits
  • How Product-centric QMS solutions enable medical device companies to achieve and maintain regulatory compliance and reduce project/compliance cost

 

Sign up today and learn tangible real-world advice to achieve compliance. Your days of hiding under your lab desk to evade an auditor’s request for evidence are over! 



Can't attend live? Register to view the webinar on-demand!

Speakers

Kim Khoe

Director, Regulatory Affairs, Quality Assurance
Apical Instruments

Kim Khoe has over 25 years of experience in the medical device regulatory affairs and quality assurance fields. Kim’s quality experience includes working as a Lead Auditor for a Notified Body in the Medical Device area, setting up the quality system at several medical device start ups, as well as hosting FDA and 3rd party audits. In the regulatory field she has filed several FDA 510(k) submissions resulting in clearances and obtained CE marks for various products. Kim currently works at Apical Instruments, a contract manufacturer specializing in the design and manufacture of Medical Devices.

Yelena Bolton

Director, Compliance (QMS)
Arena Solutions

Yelena Bolton has over 15 years of experience in Design Verification and Validation, Development, Process Improvement, and Project Management including 8 years in medical device FDA regulated environment. Prior to joining Arena Solutions, Yelena was the Project Manager at Boston Scientific and has also worked as a Proton Therapy System Validation Global Project Manager at Varian Medical, and as a Clinical Database & Validation Manager at Accuray, Inc along many others. At Arena Solutions, Yelena is responsible for QMS compliance and SW Validation. Yelena holds an MBA with double concentrations in Finance & Economics from Karazin Kharkiv National University.

Sponsor

Arena 

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