21 CFR 820 (The QSR) A practical approach to what each subpart really requires

Duration: 60 Minutes
This webinar will focus on 21 CFR, FDA 483 and warning letter observations to understand the FDA's intent when reviewing your company's quality system.
Medical Device
Instructor: David Amor
Product ID: 500485

21 CFR also called the Quality System Regulation is a 15 part regulation that looks simple enough to execute against, on paper. However, although the regulations haven't changed significantly in 30+ years, their interpretation has grown more stringent. Learn about each subpart "in a nutshell" and learn from 483 and warning letter observations to understand the FDA's intent when reviewing your company's quality system.

Why Should you Attend:
This is a very practical approach to the QSR. It teaches you about information not found in Google or forums from an instructor who has been through several FDA remediation projects for small and large companies alike.

Objectives of the Presentation:
To learn more about 21 CFR 820.

Who can Benefit:
  • Engineers
  • Quality Managers
  • Regulatory, managers
$375
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions (www.medgineering.com). David has a strong technical background, having garnered his BS and MS in Biomedical Engineering from the University of Miami with a focus on innovating around clinical needs. He is a published speaker, participating in most major medical device trade shows, including presentations at MD&M East and MD&M West, the two largest medical device conferences in the world, where he lectures on topics centering on innovative compliance practices. He also currently serves as Chief Operating Officer of ReMind Technologies, a mobile health start-up dedicated to tackling medication adherence by using smart-device based medication dispensing units and software applications.
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