Integration of risk management into the quality management system of drug distributors

Integration of risk management into the quality management system of drug distributors

Details

  • Start date: 14 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 16 December 2022
  • Finish time: 13:15 (Kyiv)
  • Duration: 2 days, 6 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): $287.

    VAT is not paid.

    $144 discounted price:

    – for each subsequent participant from one organization;

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

    $201 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: employees of all divisions of the enterprise involved in the Quality Management System (authorized person, managers, specialists of quality departments, quality control, technical service and other structural divisions of pharmaceutical enterprises).

     

    Webinar program:

    1. Purpose of the system process Quality Risk Management in a pharmaceutical company.

    2. Scope of the Quality Risk Management process in a pharmaceutical company.

    3. Procedure Quality Risk Management.

    4. Methods and principles of expert analysis for qualitative or quantitative categorization of risk factors.

    5. Risk management tools most commonly used in the pharmaceutical industry (FMEA/FMECA, Ishikawa diagram, HACCP, FTA, PHA, ranking and filtering):

    – general overview of risk management tools;

    – algorithm for applying risk management tools;

    – possible areas of application of risk management tools;

    – advantages and disadvantages of risk management tools;

    – practical application of risk management tools to improve processes and the Quality Management System (QMS) of the enterprise as a whole.

    6. Requirements for documentation of the quality risk management process:

    – Quality Risk Management protocols.