Transcription of Pharmacovigilance (Pv) Audit Checklist - Whitehall …
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Pharmacovigilance (Pv) Audit Checklist - Whitehall …
T P T : +44 (0)207 099 7432 The newly-revised Pharmacovigilance regulations shift the emphasis of the Audit process to the marketing authorisation holder. Use this Checklist to help you assess your own Pharmacovigilance systems using the prescribed risk-based aim of a Pharmacovigilance Audit is to use objective evidence to assess the appropriateness and effectiveness of the implementation and operation of a Pharmacovigilance system. The Audit must be clearly documented and can only rely on verifiable evidence, such as written records and statements. The following are typical of the factors that you should consider at a strategic planning Changes in staffing, company structure etc: Changes to key managerial function(s) Changes in the number and availability of adequately trained and experienced Pv staff.
www.whitehalltraining.com O T P T: +44 (0)207 099 7432 The newly-revised pharmacovigilance regulations shift the emphasis of the audit process to the marketing authorisation holder.
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