Journal of Developing Drugs
Open Access

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Keynote

• Leaning towards action: The who, what, why, when and how of improving quality in your supply chain

  Gerard Pearce

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• Benefit-risk balance and signal detection in the eyes of the stakeholder

  Ashraf Youssef

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• GMP at the GCP interface: What do non-commercials need to know about GMP to make GCP work?

  Patricia Henley

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• What really matters to FDA and why? A comprehensive review & analysis of FDA enforcement action on automated system validation

  James Huang

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