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Fda remediation preparation, response and execution

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OnlineCompliance Panel
OnlineCompliance Panel

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.

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FDA Remediation: Preparation, Response and Execution FDA Remediation www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
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
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
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
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
Get Connected With Us: www.onlinecompliancepanel.com www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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Fda remediation preparation, response and execution

  • 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