Two FDA Quality Systems Compliance Resources Published
24 February 2009
Two new FDA quality systems compliance resources – 'FDA Enforcement in 2009' and 'FDA Quality Systems Records Compliance' – have been published by the SmarterCompliance™ newsletter and Cerulean Associates.
Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters and other reference material designed to ease implementation of various recommendations and expert advice.
'FDA Enforcement in 2009' builds on Cerulean’s in-depth industry report from last year, 'FDA Enforcement Trends 2008-2009', and adds a review of the top ten agency inspection priorities for domestic US and international sites, four detailed self-assessment checklists, a step-by-step strategy for ensuring positive inspection outcomes, three article reprints and an hour-long audio-visual analysis of the FDA priorities for 2009, along with recommendations to stay off the FDA radar screen for the next 12-18 months. Also included is a complimentary copy of the industry report 'FDA Enforcement Trends 2008-2009'.
'FDA Quality Systems Records Compliance' includes a nine-page matrix of FDA record and documentation requirements for firms covering the GLPs, GCPs and GMPs, an 11-step strategy overview guide, several self-assessment checklists, a policy framework template, multiple article reprints and other reference materials. Also included is an hour-length audio-visual recording of the executive teleconference with questions and answers from the audience.
Both resource kit publications are available – either in download format or CD and hard copy – through the Cerulean website.
Cerulean’s next online seminar for executives, Frugal FDA Compliance: Getting More Done with Less, is scheduled for Tuesday 24 March. Visit Cerulean's website to learn more and register.
