Connieslist

  • Home

  • US Events

  • Virtual Events

  • Webinars

  • FAQ

  • Post An Event

  • Contact Us

  • More

    Use tab to navigate through the menu items.

    Connieslist

    Find events near you!

    To see this working, head to your live site.
    • Categories
    • All Posts
    • My Posts
    email
    Sep 02, 2021

    Online Webinar- "Surviving an FDA Sponsor Inspection - Training for Success"

    in Webinars

    Live Webinar: Surviving an FDA Sponsor Inspection - Training for Success When: Wednesday September 29, 2021 - 03:00 PM Duration: 100 Minutes.

    Register Now


    This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.


    This webinar will discuss how seemingly insurmountable obstacles to a successful FDA sponsor inspection were resolved and how you can apply these lessons to your next FDA sponsor inspection.


    Areas Covered in the Webinar:

    FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed

    Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement

    FDA sponsor inspection objectives and perspectives

    Typical and common FDA questions and how not to respond

    The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations

    Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection


    Register soon because space is limited.

    We hope you’re able to join us!

    0 comments
    0
    Comments