Complaint Handling and Medical Device Reporting

Speaker: Susanne Manz| Date: 21st June 2016 2016 2016 | 10:00 AM PST | 01:00 PM EST

Contact Us : Email: support@grcts.com | Tel: +1-248-233-2049

Description:

Complaint Handling and Medical Device Reporting are considered

critical processes by the FDA in maintaining the public safety. Because
they are so critical the FDA frequently inspects these areas in great
detail. More importantly, complaints can be also 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. Complaint management and MDRs are
critical quality systems to your 3 key stakeholders – the customer, the
regulators, and your business.
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

 Preparing for an FDA or NB Inspection

Who will benefit:

 QC Managers

 QA Managers and Personnel

 IT Administrators

 Regulatory Affairs

 Training Departments

 Validation Groups

 Documentation Department

 Consultants
 Instructor Profile :

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device
industry with 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. While at GE, J&J, and Medtronic, Susanne worked in
various world-wide roles including Executive Business Consultant, WW Director of Quality
Engineering and, Design Quality, and Director of Corporate Compliance.

Susanne 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.