This sterilization validation webinar teaches you how to complete the FDA eSTAR section on sterility and how to avoid common mistakes.
Sterilization Validation Webinar – $79
When you develop a new medical device, one of the decisions you make is to select a method of sterilization. Most companies select a method based on what method competitor products are using. However, the method your competitors use should not impact the sterilization method you choose.
There is one method that is less expensive to validate than any other. There are also technical reasons for selecting one method instead of another. Finally, there are clear customer preferences for sterilization methods–depending upon who is using your device and in what environment
On October 10, 2024, we are updating our sterilization validation webinar to focus on three key factors:
- What is required in the FDA eSTAR?
- How do you select a sterilization method?
- When should you avoid certain methods?
When is the sterilization validation webinar scheduled?
This webinar will be live on Thursday, October 10, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Why you should register for the sterilization validation webinar
The sterilization validation section of the 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. For FDA submissions, you are not required to submit your complete test reports for sterilization validation, but you must provide a thorough summary, or the FDA reviewer will request complete reports. This webinar will show you how to write that summary.
This sterilization validation webinar will also review the strengths and weaknesses of different sterilization methods. This will include both the category A sterilization methods (e.g., steam, gamma, and EO) and the category B sterilization methods. The selection of a sterilization method impacts your short-term verification and validation testing costs, but it also impacts how long validation will take and your long-term sterilization costs. Ethylene oxide used to be the most common sterilization method, but stricter environmental regulations are requiring that the medical device industry find innovative sterilization methods. We will discuss those newer methods during this webinar.
What you will receive for $79
- an invitation to participate in the live webinar (if you purchase before October 10, 2024)
- a recording of the webinar you can replay anytime
- the native slide deck for the sterilization validation webinar
- a copy of the FDA guidance for sterilization validation
The presentation will consist of 28 slides and will be ~50 minutes long. All content deliveries will be sent via AWeber emails to confirmed subscribers.
Q&A
Please email me questions at rob@fdaestar.com regarding the Sterilization Validation Webinar.
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 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. Rob 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 certifications. From 2009 to 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 at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.