Requirements for the Pharmaceutical Quality System (PQS) of drug manufacturers

Requirements for the Pharmaceutical Quality System (PQS) of drug manufacturers

Details

  • Start date: 01 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 02 December 2022
  • Finish time: 13:15 (Kyiv)
  • Duration: 2 days, 6 hours
  • Break: yes
  • Category: Quality (GCP, QA)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost for connecting to the webinar of one computer (participant): $215.

    VAT is not paid.

    $108 discounted price:

    – for each subsequent participant from one organization;

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

    $151 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, managers, specialists of quality services and other structural subdivisions of pharmaceutical wholesalers.

     

    Webinar program:

    1. Requirements for PQS in the Guidelines for Good Manufacturing Practice (GMP), Chapter 1, PQS

    2. Requirements for PQS in ICH Q10 Guidelines "Pharmaceutical Quality System"

    3. Differences between the "Quality Assurance" system in accordance with the previous requirements of GMP and "PQS" of the enterprise for the production of drugs

    4. Methodology for the development and implementation of PQS at the enterprise for the production of drugs

    5. Regular analysis of PQS by the management and its continuous improvement:

    • Methodology for the formation of the Report on the effectiveness of the functioning of PQS

    • Examples of formatting sections of the Report on the effectiveness of the functioning of PQS

Speakers