Boston Professional Events List


Live Webinar Development and Audit of Complaint Handling and MDR Processes


Date
Oct 09, 2017 - 01:00 PM
Organizer
wcsseminars
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
US,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
Description
A firm must implement an effective system to capture, document, correct and trend complaints, and equally important, to evaluate and identify customer feedback as to whether it qualifies as an MDR event. This webinar will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action. Also addressed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. The application of risk management to a complaint handling system will be included
 
Areas Covered

 

•    FDA requirements for complaint handling
•    Establishment of complaint handling program
•    What constitutes a complaint
•    What constitutes an MDR event
•    Evaluation of feedback as MDR: gray areas
•    The roles of investigation and corrective action in complaint handling
•    Complaint trending and reporting
•    Application of risk management to complaint handling program

 

Who will Benefit

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
•    Executive/senior management
•    Regulatory management
•    QA management
•    Any personnel who may have direct interaction with FDA officials
•    Consultants
•    Quality system auditors

 



Speaker Details


FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

 


Event Categories
Keywords: Educationa




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