Practical Guide to FDA Inspections

Duration: 60 Minutes
flat 40% off on this webinar use promo code
FDA's standard inspectional operations are discussed in the webinar so you can establish or revised your FDA inspection protocol before an inspection occurs. Most FDA inspections follow a standard procedure.
FDA Inspections Guide
Instructor: Casper E Uldriks
Product ID: 500123
The fundamental elements that require your attention include the following:
  • How FDA selects firms for inspection
  • The level of inspectional rigor applied
  • The FDA forms used and what they mean
  • Discussions and interviews with firm personnel
  • Regulatory deviations (inspectional observations)
  • FDA's evaluation and classification of an inspection
FDA conducts inspections to evaluate compliance with FDA regulatory requirements. The inspections typically follow a well established procedure. The forms issued to a firm and how the inspection will proceed can provide the foundation for establishing a firm's protocol for managing FDA inspections.

Each firm is different in terms of how it manufactures its product or conducts its professional services. The inspection is intended to adapt generic FDA requirements to the particular facts that exist at a firm. Each firm should carefully consider how this aspect of an inspection is managed. The information and documentation gathered during the inspection can be used as evidence to support regulatory or enforcement follow-up action against the firm.

Why Should you Attend:
When FDA shows up at your firm to conduct an inspection you need to create a good first impression and show that you know what you are doing in terms of conducting an inspection. If you do not know or understand the basic elements of an inspection, the process can become overwhelming and lead to situations that work against the firm. The conclusion of the inspection gives you the opportunity to gauge FDA's response to the inspection and, if appropriate, prepare a response to FDA. FDA inspections are a good example of where prior planning can avoid costly and long term negative effects.

Objectives of the Presentation:
You will learn the basic elements of how FDA prepares, conducts and evaluates inspections. With that information, you can establish, revise or test your FDA inspection protocol. An effective protocol can place you in the best possible light for your circumstances and ideally avoid misunderstandings that have costly outcomes.

Who can Benefit:
  • New to FDA Regulation
  • Never Inspected
  • Receives Complaints Associated with a Risk to Health
  • On-Going Recalls
  • History of Inspectional Problems
  • High Risk Devices
  • Investigational Products Profile
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
  • Use the login details to participate in sessions.
  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
  • Once you purchase a webinar you will receive username and password at your email address.
  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
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:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
View More