FDA Observations 2017 - Deviations and Investigations FDA Observations To Avoid Them

The GMPs require that the pharmaceutical firm complete and report an investigation of any product or process deviation or discrepancy and the FDA reviews investigations in depth in most site inspections. As a result, inadequate investigation is high on the list of FDA observations. Pharmaceutical firms either do not understand the expectation for, and value of, a thorough, timely investigation, or are not willing to commit the resources to appropriate investigations. In this webinar we will discuss the importance of and regulatory expectation for thorough, timely investigations and some of the tools that might be used during the investigation of a deviation