A Guide to Pharmacovigilance Audits in the USA
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Beschreibung
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.
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.
Discusses the process of how to effectively prepare, conduct, and develop findings associated with PV audits Provides guidance on tailoring PV audits to the individual company, product lifecycle and organizational goals Describes the intricacies associated with PV Audits
Autor*in
Heather Murphy
Themen in »A Guide to Pharmacovigilance Audits in the USA«
REMs audits PV audit conduct PV audit report How to conduct Pharmacovigilance Audits Pharmacovigilance Audits What to expect during a Pharmacovigilance Audit PV Audits FDA Regulatory Requirements PV audit preparation