When: |
18 Nov 2021 through 19 Nov 2021 | |
CFP Deadline: |
18 |
|
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/pharmacovigilance-pv-audit-gvp-sdea-sop-seminar-training-80304SEM-prdsm?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Medical-Speciality |
Keywords:
Event description:
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit 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 system and Quality System. Th...
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Posting date:
26 October 2021 | 257 views
Placement:
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