Course offering number:0910-709
Course ID:
2339
Implementing and Managing the Medical Device Complaint System
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training will benefit professionals involved in the medical device industry in departments such as regulatory affairs, QC, QA, product
development, sales, training, operations, engineering, and legal.
Description
The Complaint System will be one of the Key Systems reviewed in depth by the FDA Investigator. It is one of the major sources of issues cited
in 483's and Warning Letters.
This 90-minute accredited online training will give clear, pragmatic, instructions on how to establish elements of the complaint system; How to
recognize a complaint; Where complaints originate; Documentation of a complaint; Trending and when to investigate; What is an MDR;
Response letters; Off the shelf complaint systems; As well as how to what, when and how to communicate complaint issues to upper
management.
Several case studies from actual industry complaint systems will be used as examples of typical problems.
Module 1:
• Background-Regulatory Requirements
• Key Definitions: what is a complaint, anyway?
• What needs to be in my complaint procedure?
Module 2:
• Complaint Receipt
• Complaint Review: Is it an MDR?
• Complaint Investigations; so, why did it fail anyway?
Module 3:
• Do I need to take Corrective Action?
• Can I close this complaint already?
• What is Complaint Trending and why do I need to do it?
• Resources, Record-keeping, and other Essentials
Question and Answer Session
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