The Pharmacovigilance Quality Management System
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The Pharmacovigilance Quality Management System
The module is designed for professionals involved in quality assurance and PV compliance, PV audits, drug compliance, inspection support and/or pharmacovigilance quality documents. It is well suited for professionals involved in PV activities at a pharmaceutical company or external service provider. Personnel who are considering the PV QMS field as a future career path would also benefit from this module.
Credit Information
ACPE: 5.75
IACET: 0.6
IACET: 0.6
Description
Featured Topics:
- Quality and the quality system
- QMS regulatory framework
- Applying QMS to pharmacovigilance PV quality manual
- Quality risk management
- Quality documents
- Compliance management and monitoring
- Risk-Based and pharmacovigilance auditing
- Record management and documentation of a QMS
- Pharmacovigilance inspections and inspection readiness
- Responding to inspection and audit findings
- Corrective and Preventive Action (CAPA)