Webinar - The new QMS Normal Post COVID19 for the Pharma, Life Sciences & Medical Device Companies

Personnel Involved

PV Auditor & Quality Consultant at Canada

  • Conducting GVP Audits and Risk Assessment.

  • Conducting Gap Analysis of PV QA systems and preparation of a project plan to close the gaps.

  • Developed PV systems (PSMF, SOPs, and RMPs) for client operations in the ASEAN region.

  • Developed systems for the creation and tracking of adverse event reports as per the ICH E2B (R3) guidelines

  • Developed ADR, PSUR, RMP templates for reporting as per ICH, GVP guidelines.

  • Initiated change control of SOPs as part of CAPA for non-conformities and deviation reported.

  • Prepared license partner/ 3rd Party agreements outlining Pharmacovigilance responsibilities.

  • Facilitated Inspection by Health Canada as part of the audit response team.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in