“Helping you prepare on your journey to compliance and inspection readiness"
2015-09-24 - 2015-09-25
For further information about the event, cost and registration please contact Andrea Weber via firstname.lastname@example.org or call +421 257 272 155.
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