compliance performance Events

  • FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices

    This webinar presents important facts to simplify the planning and execution to ensure that the findings by FDA as 483s or as the more serious warning letters are addressed appropriately so your quality system is always audit proof and ready for the QSIT Inspectors. After having successfully emerged out of a FDA 483 or a warning letter for your medical devices, it is a challenge to maintain the ...


  • FDA’s Two New Draft Guidance on Software and Device Changes and the 510(k)

    This session help you implement formal methods with documented and defensible rationale—which will prepare your organization for further 510(k) changes in the future, especially if your company is in the Medical Device and combination products fields. This is a long awaited clarification of U.S. FDA’s Memo K97-1 for medical device manufacturers, with far-reaching effects in regulatory compliance ...


  • WEFTEC 2017

    WEFTEC, the Water Environment Federation’s Annual Technical Exhibition and Conference, is the largest conference of its kind in North America and offers water quality professionals from around the world with the best water quality education and training available ...


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