Category: FDA cGxP's FDA and Regulatory Issues Lean Six Sigma and Quality Improvement The Pharma Industry Pharma Workforce and Staffing Pharmaceutical Industry CEOs J&J Toyota 483's Tunnell Consulting Operational Excellence Quality Operator Error CDER OEE Ajaz Hussain Park Doctrine Accountability Misdemeanor Charges For Pharma Ceos Ray Scherzer Ken Leiper
Submitted by pharmamanufacturing on Tue, 08/31/2010 - 11:31
Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.
Category: Process Analytical Technologies FDA Pharmaceutical Process Analytical Technologies The Pharma Industry Biotechnology and biopharmaceuticals QbD Quality By Design Operational Excellence Quality CDER Ajaz Hussain Philip Morris International
Submitted by pharmamanufacturing on Thu, 05/13/2010 - 10:30
He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.
Category: Pharmaceutical Process Analytical Technologies The Pharma Industry Gawayne Mahboubian-Jones QbD Ali Afnan R&d Quality By Design Quality Ajaz Hussain Philip Morris International Optimal Industrial Automation Syntq
Submitted by pharmamanufacturing on Thu, 05/13/2010 - 08:49
Last week, Gawayne Mahboubian-Jones, one of the key thought leaders of the pharmaceutical PAT movement, left a position at Optimal Industrial Automation, whose SynTQ software is finding more users in life sciences, to join Philip Morris International as Program Manager, Excellence in Science and Design.