Seminar - Frankfurt, Germany
“Helping you prepare on your journey to compliance and inspection readiness"
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
*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
- Organization: Fleming Europe
Thu, Sep 24, 2015 - Fri, Sep 25, 2015
Le Méridien Parkhotel Frankfurt
Wiesenhüttenplatz 28-38, Frankfurt, Germany
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