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DTSTART:19700308T020000
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UID:2140535:Event:470640
DTSTAMP:20260522T172534Z
SUMMARY:PV (Pharmacovigilance) Audit Strategy Planning - A Practical A
 pproach
DESCRIPTION:The European Medicines Agency's (EMA) Guideline on good ph
 armacovigilance practices (GVP), Module IV requires that risk-based au
 dits of the quality system be performed at regular intervals to assure
  that it complies with the established quality requirements and to det
 ermine its effectiveness. It includes audit of the pharmacovigilance s
 ystem which is covered by the quality system. The GVP Modules are appl
 icable to EU-based companies and any company marketing medicinal produ
 cts on a global basis. The legally required risk based audit strategy 
 shall cover all PV processes and tasks undertaken by or delegated to o
 ther departments, MAH affiliates, and third parties such as distributo
 rs, external service providers, partners (the PV Universe). The PV Aud
 it Strategy Plan is used to prepare the PV audit program, i.e. annual 
 PV Audit Schedule.\nIn this two day workshop conference we will review
  the EMA and FDA requirements regarding Risk Based Audits of the PV sy
 stem and Quality System. The course will focus on the design of the PV
  audit strategy, identification of the PV processes and entities subje
 ct to PV audit (define the PV audit universe), development of risk ass
 essment methodology, development of procedures/tools to monitor PV pro
 cesses and activities, and implementation of the PV audit strategy pla
 n. Additionally, we will review methods of quality oversight and manag
 ement of third parties performing PV activities.\n\nLearning Objective
 s:\nUpon completing of this course, participants should be able to:\n\
 nUnderstand the legal requirements and health authority expectations f
 or a risk based audit program and current interpretation. Plan, develo
 p and implement the PV Audit Strategy Plan, which includes the followi
 ng processes:\nDevelop a high-level PV audit strategy\nIdentify the PV
  activities and processes subject to PV audit\nDevelop risk assessment
  criteria\nIdentify the PV audit universe – entities subject to PV a
 udit\nCategorize the entities subject to PV audit\nPerform risk assess
 ments\nPrioritize entities for audit according to relative risk\nPrepa
 re a 3-5 year PV audit plan\n\n\nIdentify procedures/tools to monitor 
 PV quality of third parties\n\nWho will Benefit:\nThis course is desig
 ned for people with some PV experience and tasked with developing, mai
 ntaining, updating and/or reviewing the PV quality system audit strate
 gy plan, risk assessment and/or the annual PV audit schedules. It is a
 lso beneficial for staff responsible for the quality oversight of thir
 d parties conducting PV activities.\nThe following personnel will bene
 fit from the course:\n\nPV Quality Assurance Staff\nPV Compliance prof
 essionals\nQuality auditors\nPharmacovigilance Auditors\nRelevant Phar
 macovigilance Staff\nPV Service Provider Relationship Managers\nMAH Af
 filiates responsible for Pharmacovigilance\n\n\nFor more information v
 isit https://medtechiq.ning.com/events/pv-pharmacovigilance-audit-stra
 tegy-planning-a-practical-approa-4
DTSTART;TZID=America/New_York:20220120T093000
DTEND;TZID=America/New_York:20220121T163000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/pharmacovigilance-pv-audit-gv
 p-sdea-sop-seminar-training-80304SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/pharmacovigilance-pv-audit-gvp-sd
 ea-sop-seminar-training-80304SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9829224300?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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