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2010 Archive

  • January 2010
    This issue of the PDA Letter “rings in” the results of the 2009 Board of Directors election and includes a message from Maik Jornitz, our new chair. Reports from PDA’s 4th Annual Microbiology Meeting are featured in this issue, as well as updates on PDA's four major advisory boards and a message from PDA's Bob Dana and Jim Lyda...
  • February 2010
    The February PDA Letter celebrates ICH’s upcoming 20th birthday with five articles on recent harmonization developments. These reports cover Knowledge Management, the Quality Implementation Working Group, Pharmacopeial Harmonization, Q11’s progress and new topic Q3D on Metals Limits.
  • March 2010
    The March PDA Letter features industry’s solutions to repair links in the supply chain, with four strong articles on the topic. Two articles report on sessions from the 2009 PDA/FDA Joint Regulatory Meeting, another highlights the upcoming PDA/FDA supply chain workshop, and the final feature looks to the future.
  • April 2010
    This month, in an unprecedented move, the PDA Letter staff made a decision to hold off publishing articles on ASTM standards to focus instead on the breaking news about the Health Care Reform bill. Our coverage centers on the responses of the three major pharmaceutical trade groups in the United States: GPhA, BIO and PhRMA.
  • May 2010
    The May issue of the PDA Letter contains articles about the Annual Meeting held in Orlando, Florida; the cover story, written by Walter Morris, provides an overview of the various discussions on manufacturing excellence. Learn about the Korean Food and Drug Administration in “Hailey’s Comments” in the Quality & Regulatory Snapshot;...
  • June 2010
    PDA remembers Fred Carleton in the June issue of the PDA Letter. Supply chain security and good distribution practices are discussed in three feature articles, including two reports from the recent PDA/FDA workshop on supply chain. Emily Hough discusseses her experience learning about compliance at a Metro Chapter meeting.
  • July-August 2010
    PDA remembers Raymond Shaw in the July/August issue of the PDA Letter. An article about industry’s recent challenges with aseptic processing and sterile drug manufacturing is featured. In “Hailey’s Comments” resident Korean Regulator Hailey Park discusses the drug registration process in Korea.
  • September 2010
    The latest issue of the PDA Letter takes an extensive look at how to prepare for regulatory inspections with three articles from five experienced authors. The articles are both timely and timeless, but are particularly useful in view of the new regulatory posture at the US FDA.
  • October 2010
    The latest issue of the PDA Letter marks the beginning of a series of “Meet the Instructor” interviews that will appear in upcoming issues. In this issue, enjoy a discussion between the Training and Research Institute’s James Wamsley and aseptic processing course instructor Dave Matshuiro.
  • November-December 2010
    The Nov/Dec PDA Letter features reports from the 2010 PDA/FDA Joint Regulatory Conference. Read about the U.S. FDA’s journey to join PIC/S, the International Pilot Program for Joint API Inspections, PAT’s role in QbD, and more on supply chain management.