Atlantic City is a hidden gem along the New Jersey shoreline, offering visitors much more than a seaside destination. As Atlantic City has gone through numerous transitions, the destination is in the midst of the dawn of a new era, drawing from its rich history to meet the demands of the future.
Pharmacovigilance Inspections and Audit Readiness Masterclass
“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