Friday, April 18, 2014
Presentations Minimize

Slide presentations on Rx-360 initiatives and developments related to supply chain security. 

  

Rx-360 Structure and Overview for New Members Minimize

 

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Brian Johnson's Supply Chain Security Presentation Given at the 2013 PDA Supply Chain Conference. Minimize

 

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Rogue APIs, The Ticking Bomb Minimize

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Rx-360: Working Together Means Success Minimize

 

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Informational Presentations Minimize

                                           

 

  

FDA Plans to Increase Audit Requirements for Outsourcing Minimize

Brain Hasselbalch, US FDA, Division of Manufacturing and Product Quality, Office of Compliance delivered an excellent presentation entitled Public Health Challenges for the Quality of Human Drugs at the FDA/Xavier University Global Outsourcing Conference this week.  He discussed global trends, threats to the pharmaceutical supply chain, compliance needs, corporate responsibility and outsourcing.

 

During the outsourcing part of the presentation, Mr. Hasselbalch stated that The FDA could potentially require drug makers to conduct on-site audits at manufacturing facilities run by outside contractors.  He also stressed that the FDA wants to ensure poor practices are not rewarded, and that the agency will take “swift, aggressive, and effective” enforcement action when needed to protect the public health. 

 

To view or download the presentation click here

 

  

 

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