Summary

In this course, you will get a thorough understanding of audits and inspection processes. You will learn how you as site staff and sponsor can prepare to ensure a successful outcome and what it takes to be audit and inspection ready. We will discuss who should attend, what the roles and responsibilities are, and how you can present your procedures and documentation in the most optimal way to avoid misunderstandings during the audit/inspection process. We will also look into reports, what the most common findings are, and how they are presented.

Keywords

• Audit and inspection ready
• Roles and responsibilities
• Findings/classification of findings
• CAPA
• Opening and closing meetings
  
• Dos and don’ts in audits and inspections