José Ortiz will be participating together with Brian Edwards in the faculty of the QMS training course organized by DIA.
At the conclusion of this virtual live course, participants will be able to:
• Describe how to design, develop, and manage a Quality System related to
Pharmacovigilance System
• Explain the components of the Pharmacovigilance Quality Manual
• Describe the process for the development and maintenance of the Pharmacovigilance
System Master File
• Analyze how the Pharmacovigilance Quality System integrates with the
Pharmacovigilance System
• Discuss the development, maintenance, and quality oversight of Pharmacovigilance
SOPs and Pharmacovigilance related documents, including Safety Management
Plans and Pharmacovigilance Agreements across Clinical Study programs and Postmarketing
• Assess the effectiveness of the Quality Management System
• Explain Quality Risk Management Planning for risk-based audits of the
Pharmacovigilance System and Quality System
• Define the scope of Pharmacovigilance audits, including process audits, drug specific
pharmacovigilance audits, and business partner pharmacovigilance audits
• Describe how to prepare for audits and inspections
• Practice preparing responses to a Pharmacovigilance audit and inspection findings
Participants will complete a knowledge check at the end of the course to ensure learning
objectives are attained.
The complete training programme can be found at this link:
PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us
