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FDA recommendations

Get immediate access to key recommendations from FDA officials, conference speakers and panel discussions.

 

You get all the benefits of rock-solid FDA, EU and independent expert advice ... without the cost of a consultant.

 

Each report can be purchased, downloaded to your computer, viewed and printed at your convenience.

 

FDA Conference on Enforcement Trends
FDA enforcement directors discussed the FDA's targets for enforcement in 2008-2009 and provided many recommendations.  Topics include:  clinical trial data integrity; setting up a proactive compliance and quality system infrastructure; dealing with 483s, warning letters and recalls; expectations for advertising and promotions. 18 pages $89 (USD).
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FDA Conference on Modern Quality Systems
Details the specific FDA recommendations from the November 2007 conference on current quality system expectations.  Topics include: current FDA approach for GMP and ICH compliance; recent FDA and EU inspection expectations; FDA's quality process recommendations for annual reviews and CAPAs. 14 pages $79 (USD).
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Note:  if you are a current consulting client of Cerulean, you should have already received your complimentary copy of these reports.  Please contact us if you have questions.