Webinar On How to withstand an FDA audit of your facilities A primer for clinical sites manufact
In this webinar, you will learn how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.
The FDA reserves the right to audit any facility involved in manufacture, testing or development of food and drug products. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities. FDA audits are an essential part of assuring compliance with the current regulations. Although most FDA audits are preannounced, FDA does conduct unannounced inspections of facilities that it suspects of noncompliance. FDA conducts thousands of audits each year of facilities World-wide to assure that products and services available to the American public are of acceptable quality.
FDA audits are very detailed and systemic reviews of a given facility that could span over several days, involve most personnel working at the facility under review, and if evidence of non-compliance is found, could lead to severe restrictions and/or penalties on the responsible parties. More often than not, facilities and personnel are ill-prepared and unaware of the dos and don’ts for an FDA audit and thus get into trouble for easily avoidable errors. Hence, it is very important that at all times FDA-regulated companies be aware of the regulations, logistics, and practical aspects of an FDA audit to be able to successfully withstand the same.
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