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2006 Archive

  • January 2006
    In this Issue, past PDA President Nathan Kirsh is spotlighted by Bob Myers. PDA announces its 2006 Board of Directors and Officers. Also, photos from the training session of the Kazakh health authority officials are published from one of the TRI training sessions.
  • February 2006
    The February issue features an article about the importance of secondary packaging to parenteral drug security by Carol Mooney, West Pharmaceutical Services. Jim Rittenburg, Authentix, has written about Nano-scale authetication technologies used to protect drugs and in the Science and Technology...
  • March 2006
    In this issue, a risk-based approach to ERP systems is written by Subbu Vis, ValiMation. PDA shares it's latest partenships that benefit membership, and Bob Myers and Walt Morris, PDA, report on past 'Science Trailblazers' who have introduced the Association and pharmaceutical industry to a new scientific field.
  • April 2006
    In this issue, Walter Morris, PDA, writes about a growing compliance concern in the form of personnel training. Michael Korczynski, a past PDA President, who served from 1990-1991, is highlighted. Also, the encycpedia of RMM's are elucidated by Michael Miller, Eli Lilly, and Gail Sherman, PDA clears up any training concerns in her TRI Talk.
  • May 2006
    In this issue, an interview wiht the Head of the EMEA Inspections Sector, Emer Cooke is featured; a PDA past leader spotlight highlights Clarence Kemper's reign; Arvilla Trag, Midwest Consulting Services and Ursula Busse , Medicago, write about quality system implementation in start-up medical research companies.
  • June 2006
    In this issue, David Rubin, Robert Infinger, and Peter Eichert, Millipore Corporation, write about ensuring process and product qualification through a supplier approach. Bob Myers, PDA reports on PDA's new showplace for TRI, and PDA takes an in-depth look at biopharmaceutical validation.
  • July-August 2006
    In this issue, Don Elinski, Lachman Consultants, reports on the EM of manufacturing and storage areas for non-sterile oral solid drugs. Henry Kwan, Kwan Consulting, writes about the new focus on chapters and Jim Lyda writes about the future of validation.
  • September 2006
    In this issue, Joyce Ramsbotham, Solvay Pharmaceuticals (ret.) writes about the role of the qualified person in the 21st century. Ed Fry, PDA's Regulatory Ambassador is highlighted and members exchange ideas about validating cleaning practices and microbiological count tests for disinfectant solutions in our Sci-Tech Discussions.
  • October 2006
    In this issue, Walter Morris,PDA, asks the tough question: can the U.S. FDA solve the 'pipeline problem?' Lynn Torbeck, Torbeck and Associates, queries if PAT is coming full circle to the original intentions of the GMPs and Lothar Hartmann, F. Hoffmann - La. Roche answers the over-inspection problem.
  • November-December 2006
    In this issue, PDA's dedication to dialogue and understanding between regulators is highlighted. M.L. Jane Weitzel, Watson Laboratories, writes about ISO/IEC 17025: 2005 and Pharmaceutical Testing Laboratories. Brenda Wong, FDA and Fiorence Houn, FDA report on the impact of drug preapproval inspections...