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March PDA Letter

 

Free Articles to All PDA Members and Non-Members

  • Strong Quality Agreements: Another Tool for Securing Supplies
    A session at the 2009 PDA/FDA Joint Regulatory Conference addressed the central role quality agreements can play in firming up the reliability of drug product supplies.

  • Global Supply Chain Quality Problems - What Next?
    Adulterated and defective products have made headlines in recent years, regarding contaminated heparin in drugs causing deaths, recalls of medical devices containing contaminated heparin, melamine in pet food and milk products, to name a few. Medical device companies have had problems with contractors not meeting specifications, sometimes with disastrous consequences to patients. The globalization ideal of lowering costs by sourcing materials and services from countries with low labor rates has turned out to have quality and safety risks which take a great deal of effort and expense to mitigate.

  • PDA WCC Hosts FDA Speaker at Dinner Meeting
    PDA’s West Coast Chapter (WCC) hosted their final event of the 2009 Professional Dinner Meeting Series on November 12, 2009 at the lovely Oyster Point Inn overlooking the Bay in South San Francisco, Calif.

  • Members OnlyRead the Full March Issue (Members Only)
    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. The SciTech Snapshot includes two In Prints and a Technical Report Watch. The Quality and Regulatory Snapshot includes a “Harmonization Report,” focusing upcoming joint PDA/ISPE/ICH training on ICH Q8, 9 and 10.

 
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