The document control procedure and webinar will teach you how to review, edit, and release controlled documents.
Document Control Procedure (SYS-001) and Webinar Bundle
When is the Webinar about this Document Control Procedure?
This webinar will be live on Monday, February 19, 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.
What you will receive:
Document control lists and forms are also included within this procedure. These documents are updated for the US FDA Quality System Regulation (QMSR), ISO 13485:2016, and the new European Regulations. The following is a list of documents included:
- SYS-001 v0.17, Document Control Procedure
- FRM-001 v0.3, Document Change Notice
- LST-001 v0.29, Master Document List
- LST-002 v0.2, DCN List
- TMP-001 v0.1, SYS Procedure Template
- an invitation to participate in the live webinar (if you purchase prior to February 19)
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar
If you would like to ask specific questions about the document control procedure and process, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
This document control procedure aims to ensure that documents within your quality management system are appropriately reviewed, approved, released, and accessible to those who need to use them.
The scope of this procedure covers all of the documents that form part of your quality management system. The procedure can be used with both virtual quality systems or an eQMS. You could modify this procedure to work with a Wiki to control documents.
This procedure also applies to all Marketing Communications documents. This includes brochures, website content, flyers, etc..
Records are a particular document type, excluded from this procedure but covered by SYS-002 Record & Data Control Procedure.
Customer documents that feed into the quality management system are a particular type of external document addressed in SYS-007 Customer-Related Processes Procedure.
This is the primary document meeting the applicable regulatory requirements for document control as defined in your Quality System Manual (POL-001).
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.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
About Your 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 +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.