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DTSTART:19700308T020000
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UID:2140535:Event:470608
DTSTAMP:20260603T145302Z
SUMMARY:PV (Pharmacovigilance) Audit Strategy Planning - A Practical A
 pproach to Design and Implementation
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. In this two day workshop conference we will review 
 the EMA and FDA requirements regarding Risk Based Audits of the PV sys
 tem and Quality System. The course will focus on the design of the PV 
 audit strategy, identification of the PV processes and entities subjec
 t to PV audit (define the PV audit universe), development of risk asse
 ssment methodology, development of procedures/tools to monitor PV proc
 esses and activities, and implementation of the PV audit strategy plan
 . Additionally, we will review methods of quality oversight and manage
 ment of third parties performing PV activities.\n\nLearning Objectives
 :\nUpon completing of this course, participants should be able to:\n\n
 \nUnderstand the legal requirements and health authority expectations 
 for a risk based audit program and current interpretation. Plan, devel
 op and implement the PV Audit Strategy Plan, which includes the follow
 ing processes:\nDevelop a high-level PV audit strategy\nIdentify the P
 V activities and processes subject to PV audit\nDevelop risk assessmen
 t criteria\nIdentify the PV audit universe – entities subject to PV 
 audit\nCategorize the entities subject to PV audit\nPerform risk asses
 sments\nPrioritize entities for audit according to relative risk\nPrep
 are a 3-5 year PV audit plan\n\n\n\n\n\n\nWho will Benefit:\nThis cour
 se is designed for people with some PV experience and tasked with deve
 loping, maintaining, updating and/or reviewing the PV quality system a
 udit strategy plan, risk assessment and/or the annual PV audit schedul
 es. It is also beneficial for staff responsible for the quality oversi
 ght of third parties conducting PV activities.\nThe following personne
 l will benefit from the course:\n\nPV Quality Assurance Staff\nPV Comp
 liance professionals\nQuality auditors\nPharmacovigilance Auditors\nRe
 levant Pharmacovigilance Staff\nPV Service Provider Relationship Manag
 ers\nMAH Affiliates responsible for Pharmacovigilance\n\n\nFor more in
 formation visit https://medtechiq.ning.com/events/pv-pharmacovigilance
 -audit-strategy-planning-a-practical-approa-3
DTSTART;TZID=America/New_York:20211118T093000
DTEND;TZID=America/New_York:20211118T163000
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/9746926685?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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