Site Preparation Strategy for FDA Inspections

Duration: 60 Minutes
Preparing for an FDA inspection is not as daunting as it may seem. Ensuring that your company is in a continuous state of control is the key to having a successful result with minimal findings and / or observations. The discussion will focus on pre-inspection preparation and readiness, tips during an FDA visit and post-inspection analysis and resolution. Further emphasis on personnel training and how to create a successful "back room" is presented.
FDA GMP Requirements
Instructor: David Amor
Product ID: 500433

Why Should you Attend:
FDA scrutiny is no longer reserved just for OEM companies. Over the years, contract development and manufacturing organizations have had to participate in a support role for site inspections. Navigating an inspection involves a systematic review of quality system documentation and ensuring that the right personnel are available and trained to handle the process.

Objectives of the Presentation:
  • Review of warning letters, 483 observations and other FDA inspection and quality trends
  • Review FDA inspection process and how to prepare – before they arrive
  • Key tips and tricks to navigate an inspection – once they're there
  • How to ensure that observations and findings are addressed – after they've left
Who can Benefit:
All medical device companies.

Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate 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
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
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 formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
Book This Course
  $500.00 Training CD
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
Do you want to Host
this webinar at your Organization!
Call us at +1-510-857-5896
Email us at webinar@onlinecompliancepanel.com
Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • 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.
View More