This webinar discusses FDA remediation strategies for medical device companies. It will cover how to assess, plan for, respond to, and follow up on FDA actions like 483s or warning letters through case studies and examples. The objectives are to discuss FDA remediation and quality systems. Attendees will learn best practices for preparing for and handling FDA inspections and responses. The webinar is aimed at medical device professionals and provides a recorded session for on-demand viewing along with a live interactive session.

1. FDA Remediation: Preparation, Response
and Execution
FDA Remediation
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. 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. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. Description:
FDA actions, 483s or warning letters are scary propositions - unless you know
how to assess and manage them. This course will walk students through reacting to
FDA actions or requests including assessing, planning, responding and follow-up.
Learn through case studies and actual warning letter examples on what to do and
what not to do before, during and after an inspection.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Why Should you Attend?
Attend this webinar and learn more about FDA Remediation: Preparation,
Response and Execution because all companies will go through FDA remediation at
some point.
Objectives of the Presentation:
Objectives of the presentation are to
discuss about FDA remediation and Quality System.
Who can Benefit?
Medical device professionals.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Live Session - How it works?
• Username and Password will be sent to you 24 hours prior to the webinar
• Presentation handouts in pdf format will be mailed to you
• Login to the session using the username and password provided to you
• Get answer to your queries through interactive Q&A sessions via chat
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Recorded Session - How it works?
• A link will be provided to you upon purchase of the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be mailed to you
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

7. Get Connected With Us:
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com