Compliance Corner: There Are 7 Reasons Why You're Screwing Up Management Reviews, Abbott Quality VP Says
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, lays out seven distinct issues that can keep manufacturers from getting the most out of management review meetings.
You may also be interested in...
Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data
From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
ANSI/AAMI ST79:2017 has gained four new amendments, including recommendations and clarifications for “maintaining the integrity” of sterile process areas. The standard is used by health care professionals who use steam to sterilize devices and other medical products.