Developing and Maintaining an Effective Complaint System
September 20 - 21, 2012
Amsterdam, The Netherlands
Online Registration is not available at this time. Click on the Notify Me button to the left to be notified when online registration is available.
This course is available as a client site course. Please click here for more information.
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.