This webinar explains the FDA’s 510(k) requirements for shelf-life testing. This includes a discussion of the applicable consensus standard and how to create a testing plan.
Shelf-Life Webinar ($79)
When is the Shelf-Life Webinar?
This webinar was live on Thursday, March 21, 2024. The webinar slide deck has 15 slides and the duration of the recording was 40 minutes. You can purchase it on-demand and watch the training as many times as you wish.
Why you should register for the Shelf-Life Webinar
You will learn how to avoid the most common mistakes that result in deficiencies that will delay 510(k) clearance. You will also learn how to add this information to the new FDA eSTAR template. Most important of all, you will learn why shelf-life testing is critical to review with the FDA in a pre-submission meeting.
What you will receive
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar (15 slides)
- FDA guidance for shelf-life testing of medical devices
- FDA guidance for container closure integrity testing in lieu of sterility
If you would like to ask specific questions about preparing the Benchtop Performance Testing reports, please submit them via email or schedule a call using the calendar app on our Contact Us page. All content will be delivered via AWeber emails to confirmed subscribers. Please check your spam folder if you don’t receive the content automatically.
Q&A
Please email me at rob@fdaestar.com with questions about the Shelf-Life Testing Webinar. If you have company-specific questions, please request a private call to discuss your issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your 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 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. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.