In late 2014 and the beginning of 2015 I wrote a three-part series of blogs about controlling nonconforming product. The blogs explained the three steps for controlling nonconforming product: 1) identify and segregate, 2) disposition of nonconforming product, and 3) monitoring and auditing the nonconforming material process. If you want to read the three-part series on control of nonconforming product, here are the links:

Part 1 – http://medicaldeviceacademy.com/auditing-nonconforming-materials21-cfr-820-90-compliance/

Part 2 – http://medicaldeviceacademy.com/disposition-of-nonconforming-materials-21-cfr-820-90-compliance/

Part 3 – http://medicaldeviceacademy.com/auditing-the-nonconforming-material-process-21-cfr-820-90/

What’s missing from that three-part series is specific guidance related to rework of nonconforming product. Rework is a critical area. In fact, there is a new requirement for a procedure for rework of nonconforming product in ISO 13485:2016.

On Monday, May 16 my old version of the procedure for control of nonconforming product (http://medicaldeviceacademy.com/nonconforming-product-procedureform/) will be updated and released. Later in the week, Thursday, May 19, I will be presenting a new webinar on control of nonconforming product. In addition to providing guidance for rework of nonconforming product, I am trying some new things for this webinar:

1) bundling the webinar with the new updated procedure for ISO 13485:2016 compliance

2) offering 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.

3) Provide the most entertaining webinar ever on control of nonconforming product.

Typically webinars are sold on our website for $129 and procedures are sold for $299. This bundle will be sold for $299.

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Last week we had an awesome couple of workshops at 10x in San Diego. It was the best 10x event yet! If you are interested in downloading workshop slide decks related to 510(k) submissions and CE Marking, please fill in the forms on this webpage:

http://medicaldeviceacademy.com/10x-2016/

The slide decks will be released later today along with other free downloads.

source: https://www.linkedin.com/groups/2070960/2070960-6135432924935315456