Quality Assurance Control Resource Center

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Computer System Validation: Are You Ready for an Inspection?
The topic of CSV inevitably comes up in FDA Inspections. Here's how to make sure you're prepared.

PDA 2010: Quality Risk Management from Theory to Practice: The Cangene Experience
Cangene's Jeffery Hartry shares best practices on inculcating risk management thinking and practices across an entire organization.

Focus on Pharma Podcast: Episode 3: Inside the FDA and the New Transparency Initiative
PharmaManufacturing.com
Accused of being too chummy with the drug industry, FDA has moved to improve transparency. CDER's Helen Winkle discusses the initiative's progress.

From Harmonization to Inspections: An FDA Update
A talk with FDA's CDER Office of Compliance's Division of Manufacturing and Product Quality about the state of regulatory harmonization, enforcement, and priorities for the future.

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White Papers: In Depth Research

Risk Mismanagement: Where Pharma Companies Err
Author: KPMG
Posted: 02/23/2010
In a survey of 65 life sciences execs, the Economist Intelligence Unit and KPMG found that risk management priorities are misguided. Companies fail to focus on embracing risk processes throughout their organizations, and most emphasize activities aimed at controlling regulatory risk rather than anticipating potentially greater threats.

A Quality by Design Approach to Developing and Validating Dissolution Test Methods
Author: GSK
Posted: 02/19/2010
GSK scientist Alger Salt describes how to apply QbD principles to developing and validating dissolution testing.

Tales from the Counterfeiting Front: USP’s Drug Quality Matrix
Author: USP
Posted: 10/30/2009
USP has released an updated version of its matrix tracking public reports of counterfeit and substandard drugs worldwide. The report is more anecdotal than comprehensive—there’s no way to chronicle all incidents—but tells a vivid story of the challenges facing local authorities worldwide in battling counterfeits. Also, read here about how USP and USAID are ramping up their counterefforts.

Accounting for Risk in Your Asset Management Strategy
Author: Life Cycle Engineering
Posted: 09/23/2009
A risk-based asset management system will help you appropriately prioritize how you spend time, money and materials fixing the most critical problems, provide the infrastructure for continuous improvement and help you meet your corporate business objectives, including regulatory compliance. This paper offers an overview of the three key elements of an asset management strategy and presents the six steps to building a robust, risk-based asset management program.

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