Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting
Product Code: : MDAQ-9278
Speaker : Susanne Manz
Date : 13th June 2019
Time : 11:30 AM PST | 02:30 PM EST
Duration : 90Min


Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining public safety. Complaints can be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting.

Why Should You Attend:

Because Complaint Handling and MDRs are a critical indicator of safety issues, they are top priorities for FDA inspections. The FDA uses these as focus areas to understand if your products are performing adequately and if your Quality System is effective. Even more importantly, these are vital processes for a medical device company to ensure the health and safety of their customers.

Objectives of the Presentation:

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness

Areas Covered in the Session:

  • Overview and definitions
  • FDA expectations, regulations
  • Lessons learned and enforcement case studies
  • Processes and procedures
  • Reportability criteria
  • Investigating a complaint or MDR
  • Linkages between Complaint Handling, MDRs, and CAPA
  • Common mistakes and how to avoid them
  • Best practices
  • Preparing for an FDA or NB Inspection

Who will Benefit:

  • Complaint Specialists and Managers
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Regulatory Affairs
  • Quality Engineers
  • Clinical Affairs
  • R&D Engineers and Scientists
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems

Speaker Profile:

Susanne Manz is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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Available Options

Live Session : ($179)

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Recorded Session : ($229)

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Training USB : ($319)

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Super Combo-1 : ($359)

Live Session for one Participant + Recorded Session

Super Combo-2 : ($409)

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Super Combo-3 : ($449)

Live Session for one Participant + Training USB

Corporate Live Session : ($499)

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