Pharmacovigilance Inspections & Audits Updates Videorecording

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Pharmacovigilance Inspections & Audits Updates Videorecording

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no need to travel, just sit back, relax and enjoy the learning experience

On any device

you can log in via mobile, tablet or laptop

Flexible Schedule

start when you want and follow the course at your own pace

Continuous access

you will continue to have access to the course for 3 months after completing your registration

Conveniently designed video content

the course content is divided into shorter video lectures that will allow you to increase the attention span and improve the learning experience

Full slide deck

you will be able to download the full slide deck to support your learning

Certificate of completion

upon the completion of the course you will receive the certificate of completion signed by the course leader

Course description

Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex environment for pharmaceutical companies to operate. This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.

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Pharmacovigilance Inspections & Audits Updates Videorecording by Fleming_Agenda Cover
key training

Topics

Legislative & regulatory background

Inspectional updates from global regulatory agencies – examples of findings during inspections, changing pattern of inspection findings, current regulatory expectations

Inspection preparation & conduct

PSMF maintenance

Critical PV process auditing

Interview readiness & communicating with inspectors

Audit Reports and corrective and preventative actions

Remote audits and inspections – considerations, risks and mitigations

Recommendations and practical hints & tips

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