Why you should register for the Sterilization Shelf Life Webinar
The sterilization shelf-life section of a submission is not just a paragraph referencing the recognized standards that were applied. Sterilization validation must be completed in accordance with the most recent standard regardless of which market you are seeking regulatory approval in, but the process of reviewing the sterilization shelf life data is much more involved for some processes. You also need to include information a summary of the methods used, the number of samples, a justification for sample selection, acceptance criteria and a summary of the results.
For FDA submissions, you are not required to submit your complete test reports for sterilization shelf life validation but you must provide a thorough STED or the FDA reviewer will request complete reports. On-site pre-approval inspections are sometimes required while at other times a routine inspection is merely prioritized. For Notified Body (NB) submissions, some of the NBs require an additional audit of sterilization shelf life validations to be conducted by a trained microbiologist.
Shelf life testing has always been important for EU Technical Files and the testing must be in compliance with ISO 11607-1:2007, but the FDA released a new guidance document on August 8, 2016 specific to device modifications. This new guidance includes new information regarding changes to the shelf-life of a product and when a new 510k submission will be required due to a change in the expiration dating of 510k cleared products.
What you will receive for $49
- a recording of the webinar you can replay anytime
- my updated sterilization shelf life template
- the native slide deck for this webinar
The presentation consists of 45 slides and was 47 minutes in duration. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Please submit questions to me by email at firstname.lastname@example.org regarding the Sterilization and Shelf-Life Webinar.
Sterilization Shelf Life Webinar – $49
In this webinar you will learn the requirements for Section 14 of 510k submissions. You will also learn how to format the content to ensure it also meets the requirements for a CE Marking Technical File.
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About Your Instructor
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob 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. From 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. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.