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Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

     Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry        S. Anne Montgomery, with Jeff Staecker
BPI’s editor in chief spoke with Jeff Staecker, principal consultant at BioPhia, about his view of current outsourcing trends. Those identified in this discussion set the stage for the articles that follow. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).


CMC Strategy Forum Summer 2015 Highlights

  
Highlights of CASSS CMC Forum "The Evolution of the Biopharmaceutical Control Strategy through Continued Process Verification"   What are current thoughts on continuous process verification (CPV), statistical process control (SPC), and systems to monitor and respond to data monitored?  How does this relate to QbD and product specifications?
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