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35105 Conferences

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

Added by globalcompliancepanel on 2017-08-08

Conference Dates:

Start Date Start Date: 2017-10-26
Last Date Last Day: 2017-10-27
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-10-24

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: Four Points By Sheraton San Diego Downtown, San Diego, CA, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference 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.


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.

Who will benefit:

Quality Directors and Managers
Regulatory Directors and Managers
Design Engineering Managers
Sustaining Engineering Managers
Risk Managers
Complaint Specialists
Adverse Event Reporters
Corrective Action Specialists
Recall Specialists


Day 1 Schedule

Lecture 1:
The Regulatory Structure
ISO 13485:2016 and regional variants
ISO 14971:2007 and regional variants
Implementing MDSAP
The EU Medical Device Regulation

Lecture 2:
Identification of problems
Servicing data analysis
Input to the complaint process
Lecture 3:
Identifying complaints
Evaluating complaints
Investigating complaints
Complaint data analysis
Input to the corrective action process
Input to the risk management process
Lecture 4:
Corrective Action
Developing the process
Analyzing product and process information
Determining subsequent actions
Input to the design process
Input to the risk management process
Lecture 5:
Design and Design Changes
Determining the need for a design change
Documenting design changes
Design change verification and validation
Input to the risk management process
Input to the pre-market submission process

Day 2 Schedule

Lecture 1:
Risk Management
ISO 14971:2007 and regional variants
Incorporating post-market information
Lecture 2:
Updating Pre-market Submissions
US - The 510(k) guidance
EU - Technical files and design dossiers
Canada - License changes
Lecture 3:
Adverse Event Reporting
EU - Vigilance Reports
Canada - Mandatory Problem Reporting
Lecture 4:
US - Corrections and Removals
EU - Field Safety Corrective Actions
Canada - Recall

Dan O'Leary
President, Ombu Enterprises

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Location: San Diego, CA Date: October 26th & 27th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Four Points By Sheraton San Diego Downtown 1617 1st Ave, San Diego, CA 92101, USA

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