How to Prepare for an FDA Inspections?

In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.

Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Dec-2019

Download File Only

(PPT + Recorded Training File)

Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367


Follow us:
Why Should You Attend:

All manufacturers of FDA-regulated products, including drugs, foods, cosmetics, medical devices and veterinary products, are subject to the requirements to FDA inspection. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. The prudent firm will prepare itself for such inspections, using methods such as those to be discussed in this webinar. While this webinar will focus on pharmaceutical requirements, the concepts to be discussed will be applicable to all FDA regulated products.

This webinar will give employees concepts that they can apply to their particular firm in preparing for FDA inspections. It is prudent for all FDA-regulated firms to appoint a group of employees to prepare for FDA inspection. The members of this group require training in how to prepare for an FDA inspection. The consequences of a “failed” FDA inspection (one classified by FDA as OAI) can be quite severe.

Areas Covered in the Webinar:
  • General Information about FDA Inspections
  • Inspection Classification
  • Planning for Inspections
  • Self Audit Process
  • Practice or Mock Inspections
  • Corrections
  • Responding to inspectional observations
  • FDA Warning Letters and 483s (What not to do)
Who Will Benefit:
  • Quality
  • Regulatory Affairs
  • Manufacturing
Instructor Profile:
Loren Gelber Loren Gelber

Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

More Trainings by Expert

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

You Recently Viewed