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2012 Archive

  • January 2012
    In this issue, learn about human factors testing for combination products. See the 2012 PDA Board of Directors and photos from several fall meetings.
  • February 2012
    Read about the lack of compendia harmony for visible particles and FDA’s multi-purpose audit program. Check out the Faces & Places. Learn how to nominate someone to PDA’s Board of Directors.
  • March 2012
    Follow the Annual 2012 logo for information about the meeting; articles address career development, personalized medicine and more. Also, PDA’s first PCMOSM TR is publishing. James Akers discusses <1116>.
  • April 2012
    Learn about Rx distribution licenses, targeted drug delivery and an EU directive that is meant to thwart noncompliant APIs. Read about three new PDA technical reports.
  • May 2012
    Read about designing an ultrapure water system, biofilm myths and industry and regulators’ proposals to track drug products in the supply chain.
  • June 2012
    Read about Rapid Micro Methods and PDA’s comments on three U.S. FDA biosimilar guides. View photos from the 2012 Annual Meeting.
  • July-August 2012
    The July/August PDA Letter takes a look at the difficulties associated with cleaning residues in bioreactors that form at the air-liquid interface and alternatives to cleaning, like the use of disposable systems. 10 Lessons from the recent PDA conference on sterilization are also presented.
  • September 2012
    Professional trainers explore the future of job aids within the pharmaceutical industry as companies move from paper to electronic formats. In addition, these experts discuss the importance of linking job aids to procedures that are derivatives of larger procedures.
  • October 2012
    Industry experts discuss three recently issued draft guidances concerning biosimilars with FDA representatives. Highlights from this meeting include industry recommendations to use EU regulations as a guide for U.S. standards and the need for unique, non-proprietary naming conventions.
  • November-December 2012
    In this issue, learn about the role QbD can play in vaccine manufacturing. In addition, experts discuss why quality systems should be simplified within the Industry and read tips for creating a lasting impression for preapproval inspections. Also, check out Faces & Places from the 2012 PDA/FDA Joint Regulatory Conference.

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