On Thursday, May 19 we hosted a webinar on Control Nonconforming Product. For this webinar, we tried two new things:
- We bundled the webinar with our new updated procedure for ISO 13485:2016 compliance.
- We offferred two different times for participating in the webinar live: 7am EDT & 1pm EDT. Anyone purchasing this webinar / procedure bundle will receive a recording for both webinar time slots.
Typically webinars are sold on our website for $129 and procedures are sold for $299. This bundle is sold for $299. As always, you receive a copy of the native slide deck and a link for downloading the recording (2 recordings this time). You receive the procedure for control of nonconforming product (SYS-023) which has been updated to include requirements for ISO 13485:2016. You also receive the associated forms for this procedure:
- FRM-008, Nonconforming Product Record (NCR)
- LST-008, NCR Log
ISO 13485:2016 Requirements
On March 1, 2016 the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for rework of nonconforming product in an effort to be harmonized further with US regulatory requirements.
Control Nonconforming Product Webinar Bundle – $299
The first recording of this webinar was 50 minutes in duration, but there were no questions from the audience. The second recording of the presentation was 39 minutes and there were 9 minutes of answering questions submitted. Both recordings cover the exact same slides. The presentation explains how to control nonconforming product and successfully conduct rework. All deliveries of content will be sent via Aweber emails to confirmed subscribers. You can submit any additional questions by email after you have seen listened to the recordings.
Control Nonconforming Product Procedure / Forms
The previous version of the procedure / forms is described on this website, but the updated version of the procedure has been expanded to address revisions in ISO 13485:2016 specific to rework procedures. Subscribers to this webinar bundle receive free updates to this procedure in the future when changes and improvements are made.
If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.
Control Nonconforming Product Webinar Bundle available for $299.00:
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
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.