02408nam a22004335i 4500001001800000003000900018005001700027007001500044008004100059020001800100024003500118050001400153072001600167072002300183072001500206100007800221245009600299250001800395264006900413300003400482336002600516337002600542338003600568347002400604505019500628520082400823650001801647650003001665650001401695650001801709650001901727650001401746710003401760773002601794776003601820776003601856776003601892856004601928978-3-031-73596-7DE-He21320251030113301.0cr nn 008mamaa241107s2024    sz |    s    |||| 0|eng d  a97830317359677 a10.1007/978-3-031-73596-72doi 4aRM300-666 7aMMG2bicssc 7aMED0710002bisacsh 7aMKG2thema1 aMurphy, Heather.eauthor.4aut4http://id.loc.gov/vocabulary/relators/aut12aA Guide to Pharmacovigilance Audits in the USAh[electronic resource] /cby Heather Murphy.  a1st ed. 2024. 1aCham :bSpringer Nature Switzerland :bImprint: Springer,c2024.  aXII, 146 p.bonline resource.  atextbtxt2rdacontent  acomputerbc2rdamedia  aonline resourcebcr2rdacarrier  atext filebPDF2rda0 aChapter 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.  aPharmacovigilance 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. 0aPharmacology. 0aPharmaceutical chemistry. 0aPharmacy.14aPharmacology.24aPharmaceutics.24aPharmacy.2 aSpringerLink (Online service)0 tSpringer Nature eBook08iPrinted edition:z978303173595008iPrinted edition:z978303173597408iPrinted edition:z978303173598140uhttps://doi.org/10.1007/978-3-031-73596-7