Pharmacovigilance Inspections and Audit Readiness Masterclass

“Helping you prepare on your journey to compliance and inspection readiness"
Date
2015-09-24 - 2015-09-25
Organizer
Exhibitors
2
Floor Size
200
Attendees
30
Event contact title
Mrs
Event contact first name
Andrea
Event contact last name
Weber
Email
andrea.weber@flemingeurope.com
Event contact telephone number
+421 257 272 155
Notes
For further information about the event, cost and registration please contact Andrea Weber via andrea.weber@flemingeurope.com or call +421 257 272 155.
Description
This course will give a clear understanding of what to expect of inspections as well as how to ensure full compliance with regulatory requirements. Directive 2010/84/EU legislation has navigated post-marketing drug safety towards higher standards, meaning lack of compliance will not only impact a company‘s public image but result in hefty fines. Therefore, closer communication with regulators is crucial not only for minimum compliance but for further enhancement of patient safety standards. key topics: *GVP Modules 3 and 4 *Pharmacovigilance Master File *Quality Management System *Regulatory Expectations *Audit findings *Quality Assurance *QPPV's Role within the Inspection *Interactive Session: Practical Aspects in Pv Inspections and Audits Our Prominent Trainer Shelley Gandhi Pharmacovigilance Director NDA Group, United Kingdom

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