How to prepare for a Regulatory Inspection

Benefits of attending:

By attending the webinar you will:

• Understand how to prepare for a regulatory inspection
• Know how to prepare for audit / inspection interviews
• Understand inspection procedures
• Get familiar with common inspectional observations and how to respond to them
• Improve your ability to quickly resolve any findings

Training Agenda:

• Introduction
• What is the purpose of a Regulatory Inspection?
  • Maintain regulatory compliance
  • The players
    • The Inspector
    • Management (Quality and Operations)
    • Pre-Inspection Activities
      • Doing your homework
        • Have a plan
        • Mock inspection
        • Internal audit system
  • Have a procedure in place
  • During the Inspection
    • Don’t panic
    • Interview process
      • Give the answer and nothing more
      • Review document before presenting
      • Silence is okay
  • At the end of each day
    • Daily wrap-up with Inspector
    • Daily wrap-up with Team
    • Prepare for next day
    • Post-Inspection Activities
      • Acknowledge any observations
      • Quickly resolve any findings
      • Continue to follow-up with actions until closed
      • Q&A Session

Who should attend?

The course will be beneficial for people who work in areas such as:

• Quality Assurance
• GCP (Good Clinical Practice)
• Regulatory Compliance
• Clinical Operations
• Everyone whose responsibility includes preparations for audits and inspections such as CRA group heads, line managers, heads of clinical operations, etc.

Fee:

45 EUR
Register for another webinar and get 10% discount

Date of Session:

To be confirmed

Technical Information:

Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.