Latest Quality by Design Stories

2014-08-21 23:14:15

In four hours, John Avellanet delivers proven, practical techniques for fast, flexible, flawless inspectional handling and response. Attendees will leave the session with a complete inspection SOP and an observation closure matrix, able to prove to an investigator they’re in a “state-of-control” and, if the worst happens, go from 483 observation to a coveted Untitled Letter without ever triggering a Warning Letter. Falls Church, VA (PRWEB) August 21, 2014 Flawless FDA Inspection...

2014-06-26 23:07:13

Catalent Pharma Solutions, the global leader in drug development solutions and advanced delivery technologies for pharmaceutical, biologic and consumer health products, was recently invited by the FDA Office of Compliance and Biologics Quality to speak at its Manufacturing Technology Seminar Series. The FDA had specifically requested that Catalent present on its ADVASEPT™ technology, for the advanced aseptic filling of injectable drugs, and Zydis®, Catalent’s Fast Dissolve...

2014-05-12 00:21:29

BEIJING, May 11, 2014 /PRNewswire/ -- Global Pharma Congress 2014, organized by UBM, CPhI Conference, will be held on May 28th - 29th at InterContinental Shanghai Pudong, China. 20+ speaker specialized in Pharma QbD (Quality by Design) theory and Pharma Cold Chain area are invited, including Mr. Michael Lee (Vice President of TDW Pharmaceutical), Mr. Jason Liou (Quality Director of Hansyn Pharmaceutical), Ms. Lianli Li (Senior VP of PharmaMax) and some other decision makers from...

2014-04-24 23:01:20

In a region beset by problems resulting from the disintegration of textiles, apparel and tobacco, there are a growing number of examples of a new life built upon science and technology sectors and the genuine commitment of the people of eastern NC to infuse quality in their work and the products they make. Kinston, NC (PRWEB) April 24, 2014 A US manufacturer of televisions used to promote its product with the saying ‘the quality goes in before the name goes on.’ Quality is paramount...

2014-01-07 23:29:26

Former FDA official helped pioneer science-based regulatory approaches in effect today. King of Prussia, PA (PRWEB) January 07, 2014 Tunnell Consulting, Inc. today announced that it has established a multi-year collaboration with Ajaz S. Hussain, Ph.D. and his consultancy Insight, Advice & Solutions (IAS) LLC to deliver product development, quality assurance and regulatory compliance solutions to life sciences companies. Together, Tunnell and IAS will collaborate on evolving business...

2013-12-20 23:00:49

ISPE studies on Drug Shortages and Quality by Design were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug Evaluation and Research (CDER), in her statement associated with her testimony to the U.S. Congressional Committee on Oversight and Government Reform’s Subcommittee on Energy Policy, Health Care and Entitlements. Tampa, Fla. USA (PRWEB) December 20, 2013 Two recent ISPE studies were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug...

Word of the Day
  • Like a worm in form or movement; vermiform; tortuous or sinuous; also, writhing or wriggling.
  • Like the track or trace of a worm; appearing as if worm-eaten; vermiculate.
  • Marked with fine, close-set, wavy or tortuous lines of color; vermiculated.
  • A form of rusticated masonry which is so wrought as to appear thickly indented with worm-tracks.
This word ultimately comes from the Latin 'vermis,' worm.