PV Audit and Inspection readiness – how to succeed as auditee or inspectee

About the course

Are you prepared to be audited or inspected? You better be – it is only a question of when, not if. This 1-day course is designed to give you knowledge about audit and inspection process, activities, expectations and common findings for you to be able to successfully prepare, host and respond to audits and inspections. The course consists of presentations, discussions, questions and workshop. The course focuses on Good Vigilance Practise – GVP – and is given in English.

Who should attend?

This course is recommended for

• PV personnel: both new to audit/inspection and in need of an overview or senior and wish to deepen your understanding and exchange experience and discuss practicalities
• Functions working close to PV such as QA, RA, GxP IT etc. who might be interviewed by, or asked to provide written answers to PV auditors or inspectors or who might come in contact with PV audit or inspection
• Upper Management who are ultimate responsible and accountable for operational and governance structure, resources, quality system implementation etc

Learning objectives

• Knowledge of different types and scopes of audits and inspections and the regulations and standards that apply
• Understanding of the audit and inspection processes, expectations and common findings
• Competence to prepare for audits and inspections, host, participate or support during audits and inspection and respond to any findings afterwards

Course outline

To be published.