• 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)

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.

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