FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend its practices and products is through data and documentation, meaning both structured data (database) and unstructured data (documents, spreadsheets, presentations, audio, video, etc.). Computer systems used to house, collect, modify, analyze, report, transfer, or otherwise manage both structured and unstructured data must be validated in accordance with FDA requirements to assure data integrity. By not doing so, a company leaves itself exposed to FDA scrutiny and the possibility of Form 483 citations, or even more severe consequences.Since 1953, FDA has been provided with the authority to conduct formal inspections of regulated companies, both announced and unannounced. During the inspection, an FDA auditor may have observed specific practices and/or reviewed specific data/documentation that is out of compliance with regulations. In this webinar, we will provide the most frequently cited issues to enable your company to get ahead of the curve and avoid a similar fate.Writing an effective response that will minimize the possibility of further action by the FDA is a challenging task, and should be done very carefully. In this webinar, we’ll focus on the specific best practices required to ensure an adequate response. We will also review examples of good and bad responses to gain more insight and direction for creating one.Finally, we will provide an overview and the key components of a good CAPA program. The CAPA is at the heart of a company’s response to the FDA’s findings and must be done appropriately.