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Who should attend Seminar on Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach
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
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Seminar on Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach  

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Global Compliance Panel   

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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

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Seminar Summary:

This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations. (see full course description)

 
 

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Training Course Syllabus:


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.

Agenda:

Day 1 Schedule

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

Lecture 2:
Servicing
• Identification of problems
• Servicing data analysis
• Input to the complaint process

Lecture 3:
Complaints
• 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
• US - MDR
• EU - Vigilance Reports
• Canada - Mandatory Problem Reporting

Lecture 4:
Recalls
• US - Corrections and Removals
• EU - Field Safety Corrective Actions
• Canada - Recall


Speaker:

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 Master’s 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.

Seminar Summary:

This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations. (see full course description)

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