2 Day Seminar: Managing Your Complaints and Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection (Pittsburgh, United States - May 3-4, 2018) - ResearchAndMarkets.com

Published: Apr 10, 2018

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required.

Agenda

Day One (8:30 AM - 5:00 PM)

  • Registration
  • Session Start
  • Introduction to class (20 min)
  • Complaint Handling and FDA Expectations (120 min)
  • Medical Device Reporting Procedures (MDR) (90 min)
  • MDR FDA Perspective (30 min)
  • eMDR (20 min)
  • New Guidance Documents for Postmarket Regulations (30 min)
  • Recalls: Definitions and Legal Authority (45 min)
  • Being Recall Ready -Proactive Steps to Avoid Crisis (45 min)

Day Two (8:30 AM - 4:00 PM)

  • Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
  • Elements of a Correction and Removal Report (806.10) (90 min)
  • Developing Effective Strategies and Communicating with FDA (80 min)
  • Notification Letters and Press Release (45 min)
  • Silent Recalls vs. Product Enhancements (30 min)
  • Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
  • Changes in Inspections, Look-back from Recalls and Other Field Actions (30min)
  • Termination of a Recall (15 min)
  • Mock Recall and Wrap-up (35 min)

For more information about this conference visit https://www.researchandmarkets.com/research/3pb4fh/2_day_seminar?w=4

 

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