{"product_id":"9783031735981","title":"A Guide to Pharmacovigilance Audits in the USA","description":"\u003ch1\u003eA Guide to Pharmacovigilance Audits in the USA\u003c\/h1\u003e\u003ch2\u003e\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eContributors:\u003c\/strong\u003e Murphy, Heather\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003ePharmacovigilance 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.\u003c\/p\u003e\n\n\u003cp\u003eThe 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.\u003c\/p\u003e\u003ch3\u003eBook Details\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePublisher:\u003c\/strong\u003e Springer\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e 2025-11-09\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e Paperback\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eISBN-13:\u003c\/strong\u003e 9783031735981\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePages:\u003c\/strong\u003e 146\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Springer","offers":[{"title":"Default Title","offer_id":45169228841100,"sku":"9783031735981","price":98.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9783031735981.jpg?v=1768937924","url":"https:\/\/lateknightbooks.com\/products\/9783031735981","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}