Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice. The scope is limited to the requirements based…mehr
Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice.
The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry 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.
Inhaltsangabe
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.
