Medical Device Complaints Handling Management-- One Of top Citations During FDA Inspection
Duration : 90 Minutes
This training program will discuss the basics of the Medical Device Complaint Handling Regulations and review the process for preparing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints. We will explain proper handling of complaints. What is reportable or non-reportable to FDA for a product complaint, handling and documentation, how and when to file Medical Device Reports (MDR), and key factors in implementing and maintaining compliance under 21 CFR 803 regulations and real life experiences of FDA.
Course Objectives:
Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Mistakes in identifying what is a complaint, overlooking information or warning signs of issues with can cause a company needless time and money to correct issues.
This webinar will explain:
• What Constitutes a Complaint?
• Provide an overview and answer questions related to Complaints
• Provide general information regarding how to within your Firm on a Complaint
• Establishing Complaint Files
• Help identify where you can find more detailed information on the preparation and transmission of complaints
• When Does a Complaint Become MDR Reportable
Course Outline:
• Basics of the Medical Device Complaint Handling Regulation
• Establishing a Formal Designated Unit, What Personal is needed
• How to define the process for receiving complaints
• Define the process for reviewing complaints
• Define the process for evaluating complaints
• How long are files maintained by Firm?
• Which System Works Best for Your Firm
• Readiness for FDA Inspector
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Complaint handling units
• Auditors
• Compliance officers
• Consultants/service providers
• Regulatory/legislative affairs professionals
• IT department supporting complaint handling
• Regulatory affairs reporting units
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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