Learn how to host an FDA inspector and receive work instructions when you purchase our FDA inspection webinar training bundle.
What you will learn during the FDA inspection webinar
Everyone in your company needs to know their repsonsibilities during an FDA inspection, and this FDA inspection webinar bundle will help you prepare everyone in your company. As the official correspondent to the FDA, you need to know what to ask on Friday afternoon when the FDA inspector calls you. The person greeting guests in your company’s lobby needs to know how to verify the identity of the FDA inspector and who should be notified in your company when the inspector arrives. Everyone in the company should know where the inspection meeting room is located in your company, and the FDA inspector should be taken immediately to that room. 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 they should be helping to host the FDA inspector. We discussed this during the training webinar on July 26, 2021. We are also providing this information in work instruction format (i.e. WI-009).
What will you receive when you purchase this FDA inspection webinar bundle?
Anyone that purchases this FDA inspection webinar bundle will receive a Zoom invitation to the live Zoom webinar, 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.
When is the live FDA inspection webinar scheduled?
The webinar was conducted live on Monday, July 26, 2021 @ Noon EDT. The recording is 1 hour and 21 minutes in duration. A link for downloading the recording and native slide deck are provided upon confirmation of your purchase. The “FDA Inspection Work Instruction (WI-009)” is also attached to the email providing the download links.
During the live FDA inspection webinar, we had some great questions. We also had some follow-up questions off-line. We will be converting this into an FAQ document and sending that as a follow-up to the original content. If you have company-specific questions, please use our calendly app to schedule a call with the instructor. If you are purchasing this webinar after July 26, 2021 you can still submit questions by email. You can also use our QA/RA Suggestion Box.
FDA Inspection Webinar Bundle available for $299.00:
This paid webinar will be 1-hour plus Q&A. You will learn how to prepare for an FDA inspection. You will also receive a copy of our new work instruction (WI-009) for hosting an FDA inspector that defines what you should do during the first 30 minutes of the inspector’s arrival, throughout the inspection, and in response to any FDA 483 inspection observations. There will also a quiz available for training effectivess.
FDA Inspection Webinar Topics include:
– FDA’s approach to conducting inspections
– How FDA prioritizes inspections
– QSIT approach-7 major and minor sub systems
– Types of FDA inspections
– Records exempt from FDA inspection
– “Back room” preparations for organizing the inspection
– FDA 483 dataset analysis (i.e. most common 483s in 2020)
This FDA Inspection Webinar Bundle and the “FDA Inspection Work Instruction (WI-009)” are available for $299. If you would like a quotation for a mock-FDA inspection or you would like to ask confidential questions, please use our calendly app to schedule a call with the instructor.
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?
- August 10 post…Which 483 observation trends are both worthy and instructive?
- August 17 post…Why not be fearless when it’s time for an FDA inspection?
- 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
About the Instructor
Rob Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.