http://courtsquare.libsyn.com Court Square discusses issues important to biotechs and pharmaceutical companies en copyright Court Square Data Group 2007 All rights reserved rolland@csdg.com Liberated Syndication - libsyn.com podcasts@libsyn.com (Liberated Syndication) Fri, 09 Nov 2007 18:14:00 GMT 180 Emerging biotechs face unique issues Court Square CEO discusses validation and information technology issues unique to emerging biotech companies. A discussion of each of the life cycle steps prior to FDA approval includes how best practices can create a Good Systems Practice to match efforts around GMP and GLP. pharmaceutical, biotechs, FDA, validation, drug discovery, drug development, GSP, GMP, GLP Keith Parent rolland@csdg.com Cori Rolland http://libsyn.com/podcasts/courtsquare/images/CSD logo cmyk.jpg http://courtsquare.libsyn.com Clean http://www.courtsquare.libsyn.com/index.php?post_id=276341# podcasts Fri, 9 Nov 2007 18:14:00 GMT http://www.courtsquare.libsyn.com/index.php?post_id=276341# Keith Parent No http://www.courtsquare.libsyn.com/index.php?post_id=264440# CEO Keith Parent unique IT issues facing emerging biotechs prior to NDA filing.  Potential problems are discussed and some solutions are offered.

]]> podcasts Mon, 8 Oct 2007 19:54:00 GMT http://www.courtsquare.libsyn.com/index.php?post_id=264440# Keith Parent No http://www.courtsquare.libsyn.com/index.php?post_id=261796# Court Square's Roundabout Now podcast series discusses the important organizational issues when the IT group and the QA group have conflicts.  The reasons for the conflict are explored as well as suggestions for avoiding or correcting the issue.  The impact on the drug development process is discussed.

 

 

]]> podcasts Mon, 1 Oct 2007 13:45:00 GMT http://www.courtsquare.libsyn.com/index.php?post_id=261796# 00:07:29 Biotech, pharmaceutical, organizational issues, FDA, IT, QA, Quality, Regulatory, conflict Chris Port Clean