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This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfil the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of CAPA within your organization and ensure resources are provided to meet CAPA process needs. At the end of the presentation, the speaker will answer any questions or concerns you may have regarding the CAPA process.
All medical device manufacturers are required to have a robust Corrective and Preventive Action (CAPA) system in place. Does your company have one? Is it easy to use? Does it work? Are you certain you know what CAPA is?
Corrective and Preventive Action is a process required as part of a medical device’s quality management system to ensure deficiencies are not only corrected but also prevented.CAPA is one of the most critical items of any quality system.Proper identification, correction, processing, and follow-up are needed to ensure a CAPA system is running smoothly and is effective.