Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

Course "Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system.

The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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 Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900960SEMINAR?medtechiq-October-2017-SEO

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