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	Webcast: Long, Winding Road to Pharma QbD? FDA, Wyeth Weigh In Join FDA’s Nasr and Winkle, Wyeth’s Kowolenko, and Cerulean’s Avellanet for their look into QbD’s present and future.
	The Cost of Quality: Defining the Value of Enterprise Quality Management This report by The Aberdeen Group will provide actionable steps for manufacturers to reduce the cost of quality while manufacturing higher quality products in compliance with government regulations.

EXPERT'S COMMENTS

How Quality by Design Is Changing Drug Development
By Russ Somma, PhD, President, SommaTech Consulting

Without QbD thinking, sponsors attempts to address FDA complete response letters may be doomed.

When is a CPP not a CPP?
By Alistair Gillanders, CTO, Dynochem

I had a interesting discussion recently with a colleague in one of our major pharma customers about what should be used as a CPP.

PEOPLE PROFILES

Incorporating Adverse Patient Responses into Risk Mitigation

Risk management efforts must be cross-functional; many aspects of this task can be outsourced. A brief talk with Steve Jolley, VP and Director of Pharmacovigilance at PATNI.

WHITE PAPERS

Pharmaceutical Development Case Study: "ACE Tablets"

This case study developed by FDA, Conformia, Inc., and a working group of industry experts is a milestone document on how to apply a science- and risk-based approach to product and process development for acetriptan ("ACE") 274 tablets, and how to document it in a knowledge-based report.

Using Mechanistic Modeling to Control and Improve API Manufacturing

Applying the QbD technique of mechanistic modeling to small molecule development allows for optimal process control and continuous improvement. DynoChem CTO Alistair Gillanders and colleagues explain how and provide examples in this paper.

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CALENDAR OF EVENTS

January 11, 2009 Lyophilization 2009 (54 days)
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