News

• Please Do The Right Thing Even When No One is Looking

  On September 15 2008, FDA’s final rule on “Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials” will become effective. The Rule makes “early phase 1 clinical drug development safe and efficient by enabling Read More posted Thursday, September 11, 2008 6:11 PM by axendia | 0 Comments Filed Under: News

• Interview on Closed-Loop Quality Execution and Continuous Innovation

  During a recent interview, the folks at Camstar asked that I share my thoughts on the impact that Closed-Loop Quality Execution on Life Sciences Manufacturing in the “Age of Continuous Innovation”. Visit Axendia's Life-Science Panorama to see the Read More posted Thursday, September 04, 2008 8:00 PM by axendia | 0 Comments Filed Under: News

• Regulatory Compliance - Nature or Nurture?

  Individual and organizational responses to regulatory compliance fall into one of four categories.   The great philosopher “GI Joe” said “knowing is half the battle.” Understanding an individual’s tendency toward regulatory compliance Read More posted Friday, August 08, 2008 11:09 PM by axendia | 0 Comments Filed Under: News

• Axendia’s President to Chair 3rd Annual MES for Life Sciences Congress

  YARDLEY, Pa. and WOBURN, Mass., July 9, 2008 -- Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives Read More posted Wednesday, July 09, 2008 4:25 PM by axendia | 0 Comments Filed Under: News

• Color and Glass Brighten a Sterile Facility, Lessons from IDT Biologika

  Sterile Manufacturing facilities are often, well sterile.  They are typically comprised of drab clean-rooms where the color palette is limited to stainless steel and shades of grey. For this installment of our “2008 Learning from Success” series, Read More posted Monday, June 16, 2008 10:46 PM by axendia | 0 Comments Filed Under: News

Case Studies

• Learning from Success - Building with Trust at Genentech

  Earlier this year, I had the opportunity to meet three winners of the third annual Facility of the Year Awards (FOYA) competition, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. Interviewing the leaders of these wining teams afforded Read More posted Wednesday, September 05, 2007 9:02 AM by axendia | 0 Comments Filed Under: Case Studies, News

Presentations, Podcasts, Webcasts

• Designing for Manufacturability; Closing the Loop Between Design and Manufacturing

  The integration of PLM solutions with MES (Manufacturing Execution Systems) promises to tie the product development process to the physical world of production which will dramatically improve both product innovation and design for manufacturability, especially Read More posted Thursday, July 19, 2007 7:58 PM by axendia | 0 Comments Filed Under: News, Presentations, Podcasts, Webcasts

• Innovative Strategies to Integrate Development, Manufacturing and Commercialization of Customized Medical Devices

  July 25, 20071:00pm EDT Speakers:Karim Lokas, CamstarDaniel R. Matlis, AxendiaDavid Rubin, PTC The integration of PLM solutions with MES (Manufacturing Execution Systems) promises to tie the product development process to the physical world of Read More posted Wednesday, July 11, 2007 5:40 PM by axendia | 0 Comments Filed Under: Presentations, Podcasts, Webcasts

• The Challenges of Making Life-Science from Life

  Axendia recently authored a whitepaper discussing how Biological product manufacturers seek to achieve two seemingly contradictory objectives: Implement tight controls over every step in the manufacturing processes to increase product yield and Read More posted Tuesday, June 19, 2007 7:36 PM by axendia | 0 Comments Filed Under: News, Presentations, Podcasts, Webcasts

White Papers

• Using SOA to Secure the Enterprise

  Corporations have been implementing security systems for as longs as there have been assets to protect. Today, the most valuable asset is intellectual property, and this competitive advantage is stored in bits and bytes, and whether it’s the formula for Read More posted Friday, January 12, 2007 6:45 PM by axendia | 0 Comments Filed Under: White Papers

• Want to Buy a Bridge? The Promise of Service-Oriented Architecture

  Medical device companies have been implementing manufacturing information systems for more than 30 years. These systems were often part of automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs.  Read More posted Thursday, September 21, 2006 11:55 PM by axendia | 0 Comments Filed Under: White Papers

Reference Links