Pharmacovigilance Auditing - Planning and conducting GVP Audits

- Qualifications and responsibilities according to GVP Module IV - Conducting effective interviews - Auditing of PV documents, contracts, and SDEAs - Expectations of auditors and inspectors - Risk-based audit strategy: Planning, scheduling, and executionDo you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an Auditor for Good Pharmacovigilance Practices. Secure your place on our compact, interactive online course. Book now!LernzieleIn just 1.5 days, our compact, interactive training programme will fully prepare you to conduct sound Good Pharmacovigilance Practice (GVP) audits.- After covering the basics of the EU regulatory framework, the first day focuses on the key tasks of the auditor: Conducting interviews with PV responsibilities or managers and reviewing various PV documents.Day 2 begins with a holistic view of all the areas that need to be assessed in a PV audit. Different strategies will be discussed depending on who is auditing whom and the risk-based approach to PV audits will be trained.- During the training, our qualified experts will answer many other additional questions such as: - Where can I find supporting material such as checklists, templates, and questionnaires? - What are the expectations of an inspector regarding the planning, execution, and documentation of an audit?ZielgruppenThis course will be conducted in English.- This online course is aimed at professionals and managers in the pharmaceutical industry who aspire to, or have recently achieved, the role of GVP auditor and wish to plan and conduct pharmacovigilance audits independently and confidently in the future.- Work experience in pharmacovigilance of more than three years is recommended for this course.