Description: The FDA's observational findings provide a view into the issues the agency finds most important. Through this presentation's historical evaluation of trends, companies will come to anticipate inspection questions that will arise, and ensure that the response is prepared, well-documented, and addresses the safety and public health concerns of the inspector. This presentation not only identifies inspection findings that persist as FDA priorities, but also changes in the frequency of other findings that reveal inspectional priorities that change over time. Such information can inform a company's internal audit program, to facilitate quality system improvements and operational changes so companies are better prepared for future FDA inspections. Armed with this knowledge, participants can save their companies time, energy, and disappointment by leading their teams through a focused and effective inspection preparation program.
Learning Objectives:
Summarize data on FDA-483 observations for pharmaceutical and medical device
Compare current FDA-483 observations against history
Use 483s to understand FDA’s priorities to Identify high-priority compliance actions to enhance inspection performance.