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On Demand until April 4, 2018
DURATION: 36 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.
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How to Pass a Medical Device Audit
Registration Is Closed
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By registering for this event, your information will be submitted to both BNP Media, Inc. and/or BNP Media II LLC and its affiliated brands and the event sponsor. Both BNP Media, Inc. and/or BNP Media II LLC and its affiliated brands and the sponsor may contact you via e-mail, telephone or mail with marketing offers. If you do not wish to be contacted, you should not submit your contact information for this event.
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