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2008 Archive

  • January 2008
    In the January PDA Letter, PDA’s Emily Hough and Walt Morris look at how CAPA systems are evolving through the increased focus on quality management systems. Hough also writes about how FDA wants firms to ensure their quality systems guard against data fraud, with the number of data integrity cases growing in recent years.
  • February 2008
    In this issue of the PDA Letter, PDA’sEmily Hough andWalt Morris report on Contract Manufacturing Relationships based on presentations from the 2007 PDA/FDA Conference. President Bob Myers writes about the future of PDA. The Science & Technology Snapshot includes an “In Print” from the technical book Ethylene Oxide...
  • March 2008
    In this issue of the PDA Letter, PDA’s Emily Hough reports on the current situation in China. PDA’s Walt Morris writes about possible GMPs that are upcoming based on the PDA/FDA Conference on Quality Systems that was held last November.
  • April 2008
    Just in time for April’s showers, Kristina Spitler writes a flood of arguments about why training should be considered as a part of CAPA and Stephen Bellis provides an analysis of PDA’s comments about Annex 1 to EMEA. The Science & Technology Snapshot includes an “In Print” from the technical book Microbiology in...
  • May 2008
    The PDA Letter has bloomed again and so has the PDA/EMEA Joint Conference! Reports from the conference are provided by a number of authors, including: Stephen Brown, Vivalis, andJim Lyda, PDA, on a workshop about Annex 2 Revisions, which includes an interview of one presenter by the PDA Letter; PDA’s Volker Eck...
  • June 2008
    Reminisce with this issue of the PDA Letter; this month the magazine has six pages of “Face and Places” devoted to speakers and networking events, as well as articles about our Annual Meeting. Walt Morris, PDA, writes about a story on Electroporation and its promising new uses, and about a technology trend in...
  • July-August 2008
    In our busiest issue this year, we have a Special Report on RABS from FDA’s Rick Friedman andBrenda Uratani, as well as an article by PDA’s Walter Morris and Emily Hough which features in-depth coverage of the Risk Management and Aseptic Processing Conference PDA held in May.
  • September-2008
    The September issue of the PDA Letter focuses on drug supply chain; two of the four feature articles focus on management of incoming raw materials and components of supply chain, and the two others focus on strategies for managing the distribution of temperature-sensitive drug products.
  • October 2008
    Change is in the air, or rather in the transforming leaves of the various trees outside PDA’s Bethesda office. Like the trees, PDA is changing also. In the October issue, the PDA Letter is proud to announce the electronic format of its IPQ, Journal and voting process for the upcoming 2009 PDA Board of Directors election.
  • November-December 2008
    The November/December issue of the PDA Letter is here! This edition focuses on PDA’s 3rd Annual Global Conference on Pharmaceutical Microbiology, with articles written by PDA’s Emily Hough. Destin LeBlanc, Cleaning Validation Technologies, has submitted a survey on Cleaning Validation Sampling Practices.