Who Should Attend
This course 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 3-day intensive course 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 communicate complaint issues to upper management.
Several case studies from actual industry complaint systems will be used as examples of typical problems.