A Guide to Pharmacovigilance Audits in the USA

Heather Murphy is a expert Pharmacovigilance (PV) professional with her focus in Pharmacovigilance Operations and PV Audits. For over 20 years she has established PV and reengineered PV departments for companies in various stages of development within the pharmacovigilance industry. As a result of her "hands on" experiences she has successfully developed PV systems for small-large size companies in preparation for US and global product launch. PV Operations activities have ranged from the strategic to tactical with extensive experience in PV inspections including the FDA, EMA, PMDA, AIFA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic.

Current PV audit activities include audits for/of preinspection preparation, routine and for cause, vendor qualification, REMS, business partner, contract resource organizations (CROs), specialty pharmacies, warehouse vendors, supply vendors, and distribution vendors.

She is a Certified Quality Auditor (CQA) through the American Society of Quality, obtained a MBA from Suffolk University in Boston, MA, a Bachelor of Science in Nursing (BScN) from Dalhousie University in Nova Scotia, Canada and an RN from the Prince Edward Island School of Nursing in P.E.I Canada.

Chapter 1 Introduction.- Chapter 2 Audit Types.- Chapter 3 PV Audit Preparation.- Chapter 4 PV Audit Conduct.- Chapter 5 Audit Report.- Chapter 6 Dos and Don'ts of a successful audit.