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2011 Archive

  • January 2011
    The New Year means a new look for the PDA Letter, as the staff felt it was time to enhance the design put in place in 2004. Most visual elements remain the same, but noticeable differences can be found on the cover, on the table of contents page, and on the interior page headers.
  • February 2011
    The February issue of the PDA Letter highlights the issues raised at the adventitious virus workshop. An interview with members of PDA’s new Tribromanisole task force and a report from the November ICH Steering Committee Meeting are also in the issue.
  • March 2011
    PDA President Richard Johnson highlights PDA’s plan for the year in his March PDA Letter President’s Message. Richard also discusses his visits to Korea, Japan and Taiwan late last year in his “Tales from the Trail.” This month’s feature story on Knowledge Management by Thomas Peither...
  • April 2011
    The revised guidance on process validation has raised a lot of questions, and the PDA Letter has done it’s best to bring you answers. The two feature articles look at the impact of PDA’s comments on the final guidance, implementation challenges and the FDA’s answers to some industry questions post publication.
  • May 2011
    The May PDA Letter explores ways of reducing risk in the supply chain. Several of the solutions are neatly summarized on page 22. Faces and Places returns with photos from March meetings. Also, read about the Guangdong FDA’s recent visit to PDA headquarters, and much more!
  • June 2011
    The June issue of the PDA Letter features two articles about the importance of strong internal procedures to ensure regulatory compliance: Regulatory Intelligence is the topic of the cover story and Amgen’s experience with strengthening its CAPA and Quality System following glass breakage problems is the second feature.
  • July-August 2011
    The July/August PDA Letter features an in-depth look at the value of wild-type microbial isolate testing; delamination propensity of pharmaceutical glass containers; and, lessons learned regarding microbiological investigations. This is also the show issue for the 2011 PDA/FDA Joint Regulatory Conference & TRI Courses, now in its 20th year!
  • September 2011
    Companies are always looking for ways of reducing quality deviations in their manufacturing operations, and September’s cover story presents a novel approach for doing just that. This issue also highlights four “can’t miss” sessions from the upcoming Pharmaceutical Microbiology conference.
  • October 2011
    Cover story: “Personalized Medicine: The Next Big Thing in Healthcare” by Emily Hough. Additional Features: “PDA Israel Chapter Calls for Additional Work on Q11”; “Evaluating the Use of RFID in the Pharmaceutical Industry”; “Device Usability: Getting it Right from the Start.”...
  • November-December 2011
    This issue contains five articles on sessions from the PDA/FDA Conference that emphasize recall lessons, FDA Center initiatives, FDA’s accession to PIC/S, first cycle review and process validation.