Complaint Handling and Medical Device Reporting

  • Speaker:Susanne Manz
  • Duration:90Min
  • Product Code:GRC-90362

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

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.

Objectives:

  • 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

Topics We Will Be Covering:

  • 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

Instructor:

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. 

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$249

CD-DVD: Shipped within 2 working days

$379

Recording Access to 8 Members: 6 months access to 8 participants. Recording can be accessed from any location

$749

USB - Shipped within 2 working days

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,649

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,659

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