Quick Contact : 408-458-8343
Select Page
FacebookGoogle BookmarksTwitterLinkedInPinterestEmail

Establishing a corrective and preventive action (CAPA) system is a quality system requirement for Medical Device firms marketing products in the United States. Although the FDA has always expected regulated industries to perform corrective and preventive actions, establishing a unified CAPA software system makes good business sense. The first and most important step in creating any system is to include all regulatory requirements in the firm’s standard operating procedures (SOPs). The following are seven key elements from 21 CFR 820.100 (Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.) This should be included in a firm’s SOPs: To get a handle on the CAPA system is a company wide effort. The following elements will provide what each company should do to create, maintain and leverage a sound CAPA platform.

Please fill the form below to access the resource.







    By submitting this form you agree that we store and process your personal data as per our Privacy Policy. We will never sell your personal information to any third party.

    Webinars
    x
    Upcoming
    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

    Register

       January 27, 2021   |   01:30 - 02.15 PM EST

    Follow Us