Advanced Pharmacovigilance Audits and Inspections

Using pharmacovigilance audit techniques allows a company to identify any existing gaps or risks in their systems and procedures. This allows them to define and establish priorities and company compliance.

Participants will learn how to prepare for an audit and inspection in order to achieve best practices from the moment of facing the auditing/inspection visit notification to the moment of receiving the report and its conclusions.

• Global pharmacovigilance processes
• Reconciliation process, clinical and/or spontaneous
• Safety data exchange agreements (SDEA)
• Working with contractors (audit selection and audit in the process)
• Audits of affiliates and third parties
• System and process audits
• PSMF audits
• Computerised systems audits
• Audits as preparation for a pharmacovigilance inspection
• Preparing for and undergoing a pharmacovigilance inspection

Those professionals most likely to benefit from this course will have experience in: 

• pharmacovigilance
• drug safety
• regulatory affairs
• quality assurance
• risk management
• medical affairs

or holding similar positions within the industry.

On completing this training course, participants will be able to:

• Conduct a pharmacovigilance audit based on risk assessment
• Address the different areas through system audit
• Perform a process audit
• Interview and review audit documentation
• Deal with difficult characters, missing documentation and extreme situations
• Handle disagreements on audit findings
• Review and follow-up on corrective and preventive actions (CAPAs)

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

• Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
• Mac OS X: 10.5, 10.6, 10.7
• Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirements

• Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
• Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
• Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

• Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
• Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
• Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

• Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
• Mac OS X: Intel processor, At least 512 MB RAM
• Linux: At least 512 MB RAM

Display

• 800x600 pixel resolution or greater (1024x768 pixels recommended)