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

Presented by Global Compliance Panel

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.

Course 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.

Description:

• 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.

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  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.

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  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

Agenda:

Instructors Profile:

Dan O'Leary

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.

More Seminar Information

Global Compliance Panel Summary 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. Delivery Method  Seminar Who Should Attend • 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

All Date/Location Information