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2014 Archive

  • January 2014
    The PDA Letter wishes a Happy New Year to our readers in this January issue. This issue highlight’s the impact of sterile pharmacy compounding problems on industry, including an overview of the history of regulations in this area from Eric Kastango as well as an Infographic emphasizing solutions PDA offers for those involved in compounding.
  • February 2014
    The PDA Letter examines the topic of quality metrics in this February issue. This issue offers an overview of the successful 2013 PDA Pharmaceutical Quality Metrics Conference, which led to discussion about appropriate metrics for ensuring high-quality drug products.
  • March 2014
    Follow the 2014 PDA Annual Meeting logo to read content relating to the meeting. The cover story story features Annual Meeting speakers Jeffrey Weber and Robert Tomaselli on the shift to real-time and parametric release.
  • April 2014
    The PDA Letter looks at pharmacopoeial updates in this issue. Radhakrishna Tirumalai of USP outlines recent changes to microbiology-related standards in the United States while this issue’s infographic explores the structure of the pharmacopoeias in Europe.
  • May 2014
    The PDA Letter looks at advanced therapies--an exciting new area of the industry! This issue includes an overview of Tigenix COO Wilfried Dalemans’ plenary talk at the 2014 PDA Annual Meeting in addition to an article from Jean Stanton outlining how to use QbD for cell therapy products.
  • June 2014
    Since it truly is “a small world after all,” the PDA Letter looks at recent regulatory updates in the European Union.
  • July August 2014
    Follow the logo for the 2014 PDA/FDA Joint Regulatory Conference to locate articles relating to this important forum. Marla Phillips discusses Xavier University’s Integrity of Supply Chain Initiative. Miguel Montalvo explores how CMOs and their clients can work together on effective quality management practices.
  • September 2014
    Follow the logo for the PDA 9th Annual Global Conference on Pharmaceutical Microbiology to locate articles relating to this signature PDA conference. This issue looks at environmental and financial factors impacting the future of the LAL test on its 50th anniversary.
  • October 2014
    Recruiter Ira Mann offers his perspective on the state of pharma and biotech manufacturing as well as advice for those thinking or planning to look for a new job.
  • November December 2014
    The PDA/FDA Joint Regulatory Conference is an opportunity for industry and regulators to come together and discuss the pertinent issues affecting industry as well as the latest developments in innovative medical products. In this issue, the U.S. FDA’s Geetha Jayan and West’s Erin O’Brien write about this year’s conference.