logging in or signing up Pharmacovigilance Inspections aSGuest139403 Download Post to : URL : Related Presentations : Let's Connect Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 215 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: July 13, 2012 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript PHARMACOVIGILANCE INSPECTIONS: PHARMACOVIGILANCE INSPECTIONSObjective of PV Inspections: Pharmacovigilance specific inspections are conducted by the regulatory authorities to verify that pharma companies have adequate processes and comply with the existing regulatory requirements of PV. PV data & processes are also reviewed as a part of GMP and GCP inspections Objective of PV InspectionsPreparation- the key to success (1 of 3): Review the findings of previous inspections, internal audits & third party audits Resolve all outstanding issues known for the system/facility to be inspected Review files and organization documents for completeness and validity, organize and update files and documents as appropriate Organize documents requested prior to inspection (if applicable) Preparation- the key to success (1 of 3)Preparation- the key to success (2 of 3): Inspection team Identify key sponsor contact (usually QPPv) for Europe Other members- scribe, leads for different functions (who will be interviewed), staff participating in introductory & closing meeting Preparation- the key to success (2 of 3)Preparation- the key to success (3 of 3): Don’t forget- Logistics- printing, photocopy, seating arrangement/ meeting rooms, lunch Best way to prepare Regular Self- inspection/ Internal Audits Preparation- the key to success (3 of 3)Source: This presentation is prepared from the book “Pharmacovigilance- An Industry Perspective” by Dr Deepa Arora This book includes a dedicated chapter on Pharmacovigilance Inspections Various subtopics covered in the chapter include: SourcePV inspections- subtopics (1 of 2): Scope of pharmacovigilance inspections Practices that trigger PV Inspections Risk based inspections Data covered during the inspection Process of Inspection including Notification, introductory and closing meeting & highlighting the different approaches of various regulatory authorities PV inspections- subtopics (1 of 2)PV inspections- subtopics (2 of 2): Common inspection findings Grading of Inspection Findings How to prepare for pharmacovigilance inspections How to respond to the Inspection Report/ Form 483 Examples of potential inspection findings with potential corrective & preventive action PV inspections- subtopics (2 of 2)Order your copy today, by…: e-mail firstname.lastname@example.org ; email@example.com By phone- call us at: +91- 8108699389 Cost of the book (includes delivery charges) India: INR 4000/- Countries other than India: USD 85.00 Visit our website for various Payment options- www.pharmapublisher.com Order your copy today, by… You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.