compliance software Events

  • FDA’s Two New Draft Guidance on Software and Device Changes and the 510(k)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


    ONLINE

  • FDA’s 21 CFR Part 11 Add-on Inspections

    In this webinar, our presenter John Lincoln, will address the use of the FDA guidance documents, GAMP, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. This session will also discuss and explain about a compliant, field tested (FDA and Notified Body) 21 CFR Part 11 software ...


    ONLINE

  • Dispersion Modeling for Managers - Cincinnati, OH

    This 1-day course provides environmental managers, plant managers, and others with air quality responsibilities with a broad understanding of air dispersion modeling as a tool for compliance studies or permitting submittals. The course covers the fundamental modeling concepts as well as regulatory requirements for state and federal permitting. Screening and refined modeling tools are introduced. ...


    CINCINNATI

  • Dispersion Modeling for Managers - Albany, NY

    This 1-day course provides environmental managers, plant managers, and others with air quality responsibilities with a broad understanding of air dispersion modeling as a tool for compliance studies or permitting submittals. The course covers the fundamental modeling concepts as well as regulatory requirements for state and federal permitting. Screening and refined modeling tools are introduced. ...


    ALBANY

  • Air Quality Dispersion Modelling for Managers in British Columbia - Vancouver, BC

    This 1-day course provides environmental managers, plant managers, and others with air quality responsibilities with a broad understanding of air dispersion modeling as a tool for compliance studies, permitting submittals, or air quality assessments. The course covers the fundamental modelling concepts as well as regulatory requirements for modelling in British Columbia. Screening and refined ...


    VANCOUVER

Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you