Pharmaceutical Communiqué: March - 2010

Lessons from Toyota for FDA-Regulated Companies

Toyota's reputation for quality was built over decades. It unraveled in only a few months as quality failures in its automobiles were linked to deaths, injuries and property damage on three continents. By mid-February, 37 fatalities had been reported to the US government's auto safety database in connection with unanticipated acceleration in Toyota vehicles.

FDA-regulated industries are familiar with equally tragic consequences, perhaps most painfully demonstrated in more than 100 deaths and hundreds of serious medical injuries attributed to contaminated heparin in 2008. Both industries also rely heavily on their reputations for quality and safety. Any breach in the expected standard risks a costly loss of customer trust and regulatory confidence, setting in motion a long and difficult effort at redemption.

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New Course: "Enforcement Changes at the New FDA"  

As we reported in the last Communique, our new course: "GMP Updates -- Enforcement Changes at the New FDA," (Code: PHDV91) has been released, and will be added to existing subscribers of the GMP Library at no charge.

The course focuses on agency's "Six Initial Steps" for honing the effectiveness and timeliness of FDA's regulatory and enforcement system, and includes post-inspection follow-up and warning letters.

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Audit Readiness Videos: Download the Datasheet

In our last Pharma Communique we announced the availability of our Audit Readiness Videos. We have created a datasheet so you can learn more about this video course series, which can help you and your team prepare for an inspection or audit.

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