En bref :
Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.
Learning objectives:
At the conclusion of this course, participants will be able to:
Participate in audits/inspections and mock audits/inspections
Assess how to handle the actual audit/inspection and responses to requests and findings based on the: understanding of audit/inspection methodology, the legal basis of inspections or the contractual basis of audits -Prepare responses to audit/inspection findings, including responses and corrective/preventive action (CAPA) plans
Prepare their function for an audit/inspection: roadmap, teams, tasks, and documents
Assess regional differences with respect to European and US FDA inspections
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
