HOW THE FDA EDUCATES ITS INVESTIGATORS TO CONDUCT CAPA REVIEWS AND WHAT YOU SHOULD DO TO GET READY FOR IT

During an inspection, representatives from the FDA will spend a significant amount of time analyzing the CAPA system used by your organization. What exactly are they going to search for? During this session, we will go over all of the materials that the FDA uses to teach its inspectors to assess your CAPA system. Some of these documents, which we will go over, you may not be acquainted with. A section-by-section overview of the capa subsection of the qsit, the document by which fda inspectors work when conducting an inspection, will also be included in this session. Additionally, this session will cover how your organization may utilize the same document to prepare for the inspection. areas such as these were discussed throughout the session: papers that are utilized by FDA inspectors, including the Capa Implications of Investigations Operations Manual (iom), as well as suggested means of compliance with each requirement. The implications of CPG Manual 7382.845 for CAPA, as well as the suggested compliance techniques for each requirement handbook for the qsit: an explanation of each CAPE inspectional goal, as well as the proposed compliance strategies who will come out on top: Because of the need of a capa program in the medical device, diagnostic, pharmaceutical, and biologics industries, this webinar will be of great benefit to all regulated businesses. Employees in the following departments will be eligible for benefits: R&D management regulatory management consultants in quality assurance management auditors of quality management systems rapid communication: globalcompliancepanel.com in the United States may be reached at 800-447-9407 or 302-288-6884. webinars can be requested at globalcompliancepanel.com. http://www.globalcompliancepanel.com