Articles by Karen S. Ginsbury - Pharmaceutical Technology

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Articles by Karen S. Ginsbury

Risk Mitigation and Microbial Control and Monitoring of Cleanrooms

A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms
May 1, 2013

A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms

Managing Global Change within the Supply Chain

Regulatory bodies arund the world are now revising legislation, regarding counterfeit medicines, good manufacturing and distribution practices, and risk management.
Oct 1, 2008

Regulatory bodies around the world are now revising legislation, regarding counterfeit medicines, good manufacturing and distribution practices, and risk management.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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