Workshop Pharmacovigilance Auditor

Seiring meningkatnya regulasi dan tuntutan global terhadap sistem pharmacovigilance yang efektif dan terintegrasi, dibutuhkan sumber daya manusia yang kompeten dalam melakukan audit pharmacovigilance. Audit ini berperan penting dalam memastikan bahwa sistem pharmacovigilance yang diterapkan telah memenuhi standar nasional dan internasional, serta berfungsi secara optimal untuk mendeteksi dan mengelola risiko obat.

  • 8 hours

    Course duration

  • 1 Ebooks

    Free of charge

    Why you should take this course?

        After completing this workshop, participants will be able to:
    1. Understand the basic principles of pharmacovigilance and the importance of adverse drug reaction surveillance systems;
    2. Explain pharmacovigilance audit regulations and standards;
    3. Develop audit plans, conduct audits, and prepare pharmacovigilance audit reports;
    4. Identify non-compliances;
    5. Provide improvement recommendations for the pharmacovigilance system

    What We Offer

    What's included in this online course?

    Core Pharmacovigilance & Audit Framework

    Comprehensive coverage of pharmacovigilance principles, global regulations, and audit standards to build a strong foundational understanding

    Practical Audit Tools & Case Studies

    Hands-on guidance on audit planning, execution, reporting, and real-life pharmacovigilance audit scenarios.

    Non-Compliance Analysis & Improvement Strategies

    Techniques to identify gaps, assess risks, and develop effective corrective and preventive action (CAPA) recommendations.

    dr. Hastarita Lawrenti, M.D

    A medical doctor with extensive experience in the pharmaceutical industry, currently serving as Medical and Pharmacovigilance Senior Manager at PT KF. Possessing strong expertise in pharmacovigilance systems, regulatory compliance, and patient safety, they have been actively involved in ensuring the effective implementation of drug safety monitoring in accordance with national and international regulations.

    Patrick Jones - Course author