Dan will present this webinar on April 23, Friday 08:00 AM PDT | 11:00 AM EDT. See http://www.complianceonline.com
Acceptance activities should be easy for device manufacturers. As one of the FDA’s most frequently cited sections in Warning Letters, however, there are issues and problems in this area of the regulations. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
This webinar will clear up the regulatory requirements, and help you plan effective and compliant acceptance activities. We look at the regulations and explain what they mean. In addition, we look at the QSR preamble to help clarify the intent and expectations. By analyzing recent Warning Letters, you can learn from the mistakes of others, and ensure your acceptance activities fully comply with both good practice and the regulatory requirements. The Warning Letter review follows an analysis of the regulations using the QSR preamble and the guidance from FDA’s QSR Manual. We look at the process description and usage of the document.