Medical Devices Complaint Handling Best Practices

 

Program Speaker: 

Mary Carvajal

Independent Quality Consultant

 

Event Agenda:

DATE: Wednesday 19 March 2025

TIME:

6:00 –  6:05 PM Welcome and Announcements

6:05 –  6:10 PM Introduction to Eric Henry

6:10 –  7:05 PM      

LOCATION: This event is being offered only virtually. The zoom link will be shared with you via email 1-2 days before the event.

Registration Information:

• Register for the event here

Program Highlights:

• Overview of FDA/OUS complaint-related regulations including MDR/Vigilance Reporting.

 

• Complaint handling basics: how to receive product feedback, determine whether information constitutes a complaint, good faith efforts to obtain missing or clarification of information, complaint investigation determination, monitoring & trending, and good documentation practices to ensure a compliant record.

 

• Case study to help understand common pitfalls and suggestions on handling these challenges and tools for practical process implementation.

 

• MDR/Vigilance basics: how to determine reportability and common pitfalls.

 

• Case study to help understand common pitfalls and suggestions on handling these challenges and tools for practical processes.

• Associated quality sub-systems and considerations: Risk Management, CAPA, Corrections and Removals, and Servicing.

Speaker Biography:

Mary Carvajal has been an independent quality consultant/owner of an LLC since 2011 and has 35+ years of experience in Biologics, Medical Devices, IVD, Biotech, and OTC industries.

Holds a Bachelor of Science- Business Management, Medical Product Development Certificate and is a Certified Quality Auditor (CQA), ISO 13485:2016 Lead Auditor, IVDR, EU-MDR, and MDSAP per Exemplar Global Competency Unit, as well as a prior OCRA Guest Speaker/Volunteer/Mentor.

Expert in analyzing and navigating complex fast-paced quality environments and developing effective strategies for remediations, sustaining QMS compliance, and knowledge transfer/mentoring.

Experienced in managing effective quality management system (QMS) strategies and implementation that allow companies to maintain their products on the market and sustain compliance efficiently.

Expert in analyzing and navigating complex fast-paced quality environments and developing effective strategies for remediations, sustaining QMS compliance, and knowledge transfer/mentoring.

Extensive experience in global complaint handling and MDR/Vigilance reporting. Including, but not limited to, complaint investigations, root cause analysis (RCA), CAPA, non-conformance (NC), field corrective action (FCA),

Document Control, Internal/Supplier Audits, Supplier Controls, Complaint/CAPA backlogs, Recalls, Warning Letters, Consent Decrees, Training/Mentoring of Staff.

English/Spanish and experienced with various e-QM systems (i.e., Salesforce, SmartSolve, TrackWise, Agile, SAP, CATSWeb, etc.).

Contact 

[email protected] 

Pricing – Online – Registration (ends Tuesday, March 18, 2025)

 

 

Registrant Type	Event Price
Member	$10.00
Lifetime	$10.00
Non-Member	$20.00

 

 

Cancellation Policy

 

 

There will be no refunds for cancellations.