A Guide to Pharmacovigilance Audits in the USA [electronic resource] / by Heather Murphy.

Por: Murphy, Heather [author.]Colaborador(es): SpringerLink (Online service)Tipo de material: TextoTextoEditor: Cham : Springer Nature Switzerland : Imprint: Springer, 2024Edición: 1st ed. 2024Descripción: XII, 146 p. online resourceTipo de contenido: text Tipo de medio: computer Tipo de portador: online resourceISBN: 9783031735967Tema(s): Pharmacology | Pharmaceutical chemistry | Pharmacy | Pharmacology | Pharmaceutics | PharmacyFormatos físicos adicionales: Printed edition:: Sin título; Printed edition:: Sin título; Printed edition:: Sin títuloClasificación CDD: 615 Clasificación LoC:RM300-666Recursos en línea: Libro electrónicoTexto
Contenidos:
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.
En: Springer Nature eBookResumen: 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.
Star ratings
    Valoración media: 0.0 (0 votos)
Existencias
Tipo de ítem Biblioteca actual Colección Signatura Copia número Estado Fecha de vencimiento Código de barras
Libro Electrónico Biblioteca Electrónica
Colección de Libros Electrónicos 1 No para préstamo

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.

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.

UABC ; Perpetuidad

Con tecnología Koha