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Get the Facts and Stay Out of Trouble

Get immediate access to key recommendations from FDA officials and expert advice ... without the cost of a consultant or an FDA inspection.

 

An Executive's Guide to Quality by Design

This short report highlights the history of the FDA's Quality by Design for biopharmaceutical and medical device executives. The guide overviews Quality by Design concepts from preclinical to postmarket. Download your complimentary copy of An Executive's Guide to Quality by Design.  (PDF)

 

Is Quality by Design (QbD) Right for My Organization...?

Filled with facts, questions to answer, plus an innovative starting blueprint of five tactics to speed your time to market and reduce your costs by 12%, this 36-page workbook is designed to help you assess if Quality by Design is appropriate for your company now or if you should continue waiting.


Price: $23 (USD)

After purchase, make sure to click on the "Return to Cerulean" button to download your report.

 

FDA Quality by Design and Modern Quality Systems

Details many recommendations from FDA officials on 21st century quality systems expectations and incorporation of Quality by Design.  Topics include: current FDA approaches for GMP and ICH compliance; recent FDA inspection expectations; recommendations for annual management reviews and CAPAs; top 3 ways inspectors look for you to demonstrate your intent to comply; updated insights on applying risk management throughout your compliance infrastructure ... and more.


Price: $37 (USD)

After purchase, make sure to click on the "Return to Cerulean" button to download your report.

 

Protecting Biotechnology Intellectual Property

Written by one of the leading experts in the field with more than 16 years of experience setting up trade secret and intellectual property theft prevention programs, this walks your through an eight-step strategy to put in place your own intellectual property protection program - with tips for startups on no-cost/low-cost approaches, and examples drawn from real-life.  Topics include:  how best to leverage your lawyer's advice; setting up reasonable policies that scientists and engineers will follow; balancing security with open innovation ... and more.


Price: $44.00 (USD)

After purchase, make sure to click on the "Return to Cerulean" button to download your report.

 

Additional Details

All documents can be purchased, downloaded, viewed and printed at your convenience.  Once you place your order, you will be given immediate access to the document and may download it for the next seven days.  We accept MasterCard, Visa, Discover, American Express and PayPal for payment.

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If you have any questions or would prefer to pay with purchase order or check, contact us.

 

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