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

Event Details

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

Time: October 26, 2017 at 9am to October 27, 2017 at 6pm
Location: Four Points By Sheraton San Diego Downtown
Street: San Diego, CA
City/Town: San Diego, CA
Website or Map: http://www.globalcompliancepa…
Phone: 800-447-9407
Event Type: online, healthcare, training, courses
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Aug 10

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Event Description

 

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.

 

Why should you attend:

 

To have an effective and efficient QMS you need to understand how to implement the related QMS processes. Developing the processes involves implementing best practices, but that doesn't necessarily meet all the regulatory requirements. With the introduction of ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation, you will need to update your QMS and integrate all of the elements to assure an effective and compliant implementation. This workshop provides the tools you will need.

 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

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

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

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