In our new distribution procedure webinar you will learn how to maintain product distribution records in case of a potential recall.
Distribution Procedure (SYS-015) Webinar Bundle
This procedure defines your company’s distribution process. It pertains only to physical devices, while software distribution is managed by our software development and validation procedure (SYS-044). This procedure is the primary document meeting the applicable regulatory requirements for distribution as defined in the Quality System Manual (POL-001). It applies to medical devices distributed in the United States, Canada, and the European Union and has been written to conform with ISO 13485:2016.
When is the webinar about this distribution procedure?
This webinar will be live on Monday, April 1, 2024, at 10:30 a.m. ET. It will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
What you will receive:
A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-015, Distribution Procedure
- LST-015, Distribution Log
- Native Slide Deck for Training Webinar
- Recording of Training Webinar (April 1, 2024)
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
About the Speaker
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.
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To review a sample Medical Device Academy procedure click below:
