FDA inspection webinar – Updated for 2026 Guidance

Learn how to host an FDA inspector and receive work instructions when you purchase our FDA inspection webinar training bundle.

What you will learn in the FDA inspection webinar

Everyone in your company needs to know their responsibilities during an FDA inspection, and this FDA inspection webinar bundle will help you prepare them. As the official FDA correspondent, you need to know what to ask on Friday afternoon when the FDA inspector calls (if they call in advance). The person greeting guests in your company’s lobby needs to know how to verify the FDA inspector’s identity and who to notify within your company upon the inspector’s arrival. Everyone in the company should know where the inspection meeting room is, and the FDA inspector should be taken there immediately. Don’t make them wait in the lobby. How you handle the first 30 minutes of an FDA inspection makes an important first impression on the FDA inspector. Once the FDA inspection begins, each person in your company needs to know how to help host the FDA inspector.

FDA Medical Device Inspection Guidelines – QMSR Update for 2026

On February 2, 2026, the FDA released a new medical device inspection guidance document to replace the obsolete QSIT manual. The FDA inspection work instruction (i.e., WI-009) was updated to reflect this new guidance. The training webinar was also updated to reflect the new guidance. Customers who purchased this work instruction bundle will receive an email notification when the updated content is available.

What will you receive when you purchase this FDA inspection webinar bundle?

Anyone who purchases this FDA inspection webinar bundle will receive the “FDA Inspection Work Instruction (WI-009)” in the native Word format, any future updates to the work instruction, access to a recording of the webinar, and a quiz for verifying training effectiveness. The webinar was prerecorded in February 2026. The recording is ~90 minutes long. An unpublished link to a YouTube video will be included in the updated work instruction (see training section). The “FDA Inspection Work Instruction (WI-009)” is provided as a link to a Word file in Dropbox.

Q&A

If you have any questions about FDA inspections, please post them as a comment on our YouTube channel. If you have company-specific questions, please schedule a call with Lindsey Walker. She can provide you with a quote for a mock FDA inspection or for hourly consulting with one of our consultants.

FDA Inspection Webinar Bundle available for $299.00:

Hosting an FDA inspection (Training Bundle)

This is a prerecorded webinar explaining how to prepare for an FDA medical device inspection under the new 2026 FDA inspection guidelines. The webinar is ~90 minutes long. You will also learn how to conduct mock FDA inspections. You will receive a copy of our updated FDA inspection work instruction (WI-009), and link for the unlisted YouTube video is in the training section of the work instruction. There will also be a quiz available for training effectiveness. FDA Inspection Webinar Topics include: 1) what to do during the first 30 minutes, 2) FDA’s approach to conducting inspections, 3) How FDA prioritizes inspections, 4) the new 6 inspection areas and general areas, 5) Types of FDA inspections, 6) Records exempt from FDA inspection (there are none), 7) “Back room” preparations for organizing the inspection, 8) FDA 483 dataset analysis (i.e. most common 483s in 2020), and 9) How to respond to any 483 inspection observations.

Price: $299.00

This FDA Inspection Webinar Bundle and the “FDA Inspection Work Instruction (WI-009)” are available for $299.

Important Note

This FDA inspection webinar will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. The email may be in your spam folder.

Additional resources to prepare for an FDA inspection

In addition to our FDA inspection webinar, you may also be interested in the following blog articles related to FDA inspections:

• Smile, because you should never be scared of a surprise FDA inspector
• Are you a little curious, or fascinated by competitive warning letters?
• Does your FDA inspection plan need to be proactive first?
• FDA 483 Inspection Observations Pareto Chart for FY 2015 (To be update 2/10/2026)
• Strategic planning of a mock FDA inspection
• 8 success tips for the first 30 minutes of an FDA inspection
• 10 FDA Inspection Strategies that DON’T Work
• 5 Classic blunders that result in an fda warning letter from CDRH
• 7 Steps to writing an FDA 483 response
• How to Utilize CAPA Training To Avoid FDA 483 Citations