Advanced Pharmacovigilance 2021 - 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections

PV Audit Strategy Planning course will provide an overview of the European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness.
In this three day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes
Review of FDA and EMEA requirements for risk based PV audits
The pharmacovigilance system and the quality system
Strategic level audit planning
Speaker:
Cynthia is an accomplished executive director and chief compliance officer with over 17 years’ experience providing first-to-market solutions to the challenges sponsor face whilst using risk management strategies to mitigate ones in the future.