Enhancing Compliance through Novel Approaches to Commissioning & Qualification/Validation (CQV) of Automation, Facilities, Utilities, and Equipment Systems used in Biologics Manufacturing
Posted on March 1, 2017
Brian Urban, Associate Director, Quality Systems and Enterprise Management, Corporate Quality
Biogen, Research Triangle Park (RTP), US
Tolga Musa, Associate Director, Process Engineering
Biogen, Research Triangle Park (RTP), US
Robert Smith, Sr. Manager, Automation Engineering
Biogen, Research Triangle Park (RTP), US
Jacob Grønnegaard, Associate Director, Engineering Next Generation Manufacturing
Biogen, Hillerød, Denmark
Abstract Historical approaches to automation, facilities, utilities, and equipment validation mitigated risk through large amounts of documentation and testing. The foundation of the next generation approach is driven by a risk profile (e.g., ICH Q9 (Quality Risk Management)), which clearly defines ...
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Related Topics and Keywords
automation, biogen, Brian Urban, Jacob Grønnegaard, Qualification/Validation, QVC, Robert Smith, Tolga Musa
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