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Seminar & Resource Kit Details

Introduction to Speeding Drug Development with Quality by Design

CD includes the one-hour presentation and Q&A session with attendees plus all the individual slides, reference material and customizable training certificate.  Speaker: John Avellanet. Event ID: 737065

 

Summary

Companies that have effectively adopted Quality by Design have seen 31% faster product development, 18% lower costs, success rates that are 3x better and a return on their investment that is nearly 4x greater.  If you're not getting these results from your drug or biologic development program, maybe it's time you learned why.

Based on Cerulean's full-day corporate workshop on Quality by Design, this 60-minute, information packed seminar lays out a high-level strategy for adopting Quality by Design.

How are you adapting the FDA and ICH's expectations to your development programs?

This recorded seminar presents key takeaways from recent FDA officials, conferences, publications, plus consulting client case studies and successful tactics from peer executives in Cerulean's SmarterCompliance™ program.

You will learn:

• Why the FDA has decided that Quality by Design is the critical path

• The differences between Quality by Design and traditional development programs

• Results of several key case studies

• Eleven key reasons to implement Quality by Design

• Why the FDA is expecting Quality by Design compliance by 2012

• Five steps to take immediately to start fitting Quality by Design into your company

• And much more

On the CD:

• Customizable training certificate

• Printable speaker's slides

• Synchronized audio-visual recording of the presentation and Q&A session

• Regulatory Reference documents:

  • FDA Guidance:  Early Development Considerations for Innovative Combination Products

  • FDA Guidance:  PAT - A Framework for Innovative Pharmaceutical, Manufacturing and Quality Assurance

  • FDA Paper:  The Critical Path to New Medicinal Products

  • ICH Annex Q8 Pharmaceutical Development

  • ICH Q8 Pharmaceutical Development

• Literature Reference papers:

  • Article Reprint:  Quality by Design:  Defining Your Preclinical Package

  • Article Reprint:  Process Analytical and Working with IT

  • Article Reprint:  Annex to Q8 - Quality by Design in Product Development

  • Article Reprint:  Elucidation - Lessons from the Auto Industry

  • Report:  Why Quality by Design?  An Executive Guide

• And more

This seminar will help you put in place aspects of Quality by Design that will kick-start your development programs into higher gear.

Your purchase also includes a complimentary six-month trial to the SmarterCompliance newsletter of FDA intelligence, practical quality systems advice, and regulatory compliance analysis ($144 value).

 

About the Presenter

John Avellanet is a well-known leader in lean compliance and quality systems management.  He is a frequent and sought-after speaker for corporate management workshops, trade association conferences, business schools, and forums such as FDAnews, FOI Services, PharmaQbD, the Management Roundtable, and Expert Briefings.  He publishes the monthly executive newsletter, SmarterCompliance™, has written more than 30 articles syndicated in biopharmaceutical and device journals world-wide, and is a co-author of the book, Best Practices in Biotechnology Business Development.  Many of his clients and SmarterCompliance™ subscribers view him as their senior  compliance and quality advisor.

 

To Order

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CD or Download

CD (default) - $325.00 Download - $325.00

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Additional Details

The purchase price for the recorded seminar is $325 USD (shipping is free).  We accept MasterCard, Visa, Discover, and American Express through PayPal for online payment.

For details on how PayPal secure credit card payment works, see below.

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

 

Secure Payment

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• Input your shipping and billing information.  You do not need a PayPal account.

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