Skip to main content
Monitoring, Quality & Inspection Readiness

Inspection Readiness: Defend the Record in a Mock Inspection

Coming soon

Answer inspection-style questions from the record itself, and see where the record does not hold up.

This course is still being built. Lessons are not available yet, and there is no enrollment, payment or certificate for it at this stage.

Advanced · Self-paced

Inspection readiness artwork: a mock inspection meeting with trial master file binders, checklists and a magnifier over the record, in BORAKA navy and teal.

What this course covers.

Who it is for
Site, quality and study teams preparing for inspection.
What you will be able to do
Locate supporting records, answer evidence-based questions and identify gaps requiring corrective action.
What you will produce
An inspection question set answered from the record, with a gap list.
Systems referenced
No specific system access is required for this course.

Topics

  • Record retrieval
  • Evidence-based answers
  • Gap identification
  • Corrective action

All scenarios used in Academy courses are fictional practice material. Course work is practice, not employment experience, and it is not a verified competency result.

Register your interest in this course

Register your interest in this course.

Tell us a little about where you are now. Registering interest is not an enrollment and does not reserve a place.

  • Monitoring judgment artwork: a reviewer turning source notes and data listings into defensible findings, in BORAKA navy and teal.
    Coming soon

    Monitoring judgment

    Separate what you noticed from what you can evidence, and rank what actually needs follow-up.

  • Monitoring reports artwork: a findings report moving from site notes to clear actions for a study team, in BORAKA navy and teal.
    Coming soon

    Monitoring reports

    Turn rough visit notes into a report a site can act on without a second phone call.

  • Protocol deviations and CAPA artwork: a deviation report, root cause diagram and corrective and preventive action plan, in BORAKA navy and teal.
    Coming soon

    Deviations and CAPA

    Get past the first explanation of a deviation and build a corrective plan that holds.