This eLearning course covers organizational structure, responsibilities, processes, and resources required for Pharmacovigilance Quality Management Systems (PV QMS). The module describes how elements of the PV QMS fit together to achieve quality and regulatory compliance.
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)
Who should attend?
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.
Learning objectives
Upon completion of this course, learners should be able to:
Recognize the characteristics and benefits of a PV QMS
Differentiate between the elements of the regulatory framework that govern a PV QMS
Differentiate between the components of a complete PV Quality Manual
Select ways in which a PV QMS integrates into a PV system
Recognize characteristics of effective development, maintenance, and oversight of PV QMS documents
Identify factors for measuring and monitoring the effectiveness of a PV QMS
Select defining factors of successful risk-based audits of the PV QMS and define the audit universe
Sequence steps for effective preparation for audits and inspections
Classify PV audit or inspection observations and findings
Recognize elements of an effective Corrective and Preventive Action (CAPA) plan