Developing Effective Post Market Surveillance and Complaint Handling Requirements

Description

SEMINAR DESCRIPTION

Non-conformances, complaint handling, trending, closed-loop CAPA, and other pre- and post-market surveillance systems mandate a repeatable, systematic Failure Investigation and Root Cause Analysis with follow-up. These are often discussed, but little understood disciplines among those who could benefit most from its use. With reason, the most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. However, one of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, effective post-market surveillance, continuous product improvement, and an improved bottom line.