Good practice in the distribution of substances – an overview of new regulatory requirements

Good practice in the distribution of substances – an overview of new regulatory requirements

Details

  • Start date: 07 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 07 December 2022
  • Finish time: 13:15 (Kyiv)
  • Duration: 3 hours
  • Break: yes
  • Category: Distribution (GDP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost for connecting to the webinar of one computer (participant): $173.

    VAT is not paid.

    $87 discounted price:

    – for each subsequent participant from one organization;

    – students, subject to the presentation of a student card.

    $121 discounted price:

    – clients of the Conformity Assessment Body UKRMEDCERT LLC and GXP UMEDCER LLC.

     

    The price includes: information service, video recording of the webinar, a set of training materials and a certificate in pdf format.

     

    Target audience: authorized persons, quality directors, senior and middle managers, leading specialists of quality services, incl. departments of management (assurance) and quality control, production managers, technologists, managers and specialists of personnel management services, heads and leading specialists of engineering departments of drug manufacturing enterprises.

     

    Webinar program:

    1. Legislative and regulatory norms regulating the distribution of active pharmaceutical ingredients (APIs) in the EU and Ukraine.

    2. Overview of API Good Distribution Practice requirements:

    • Scope of application;

    • Quality system;

    • Personnel;

    • Documentation;

    • Premises and equipment;

    • Activity (distribution process);

    • Return, claim and recall;

    • Self-inspection.