Conducting external and internal audits (self-inspections) in accordance with the requirements of good practices (GMP, GDP)

Conducting external and internal audits (self-inspections) in accordance with the requirements of good practices (GMP, GDP)

Details

  • Start date: 08 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 09 December 2022
  • Finish time: 13:15 (Kyiv)
  • Duration: 2 days, 6 hours
  • Break: yes
  • Category: Production (GMP)
  • 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, quality directors, managers and leading specialists of management (security) and quality control departments, warehouse managers and other specialists of business entities that carry out or plan to carry out economic activities for the production, import of medicines, wholesale trade in medicines.

     

    Webinar program:

    1. Definition of the concept of "audit". Terms and Definitions. Types of audits.

    2. Requirements of international standards (ISO 19011:2018) and good practices (GxP) for audits.

    3. Principles of conducting audits.

    4. Requirements for auditors. Principles of forming an audit team.

    5. Planning and organization of audits.

    6. The purpose and objectives of the audit. Audit criteria. Audit plan and program.

    7. Stages of the audit.

    8. Technique for conducting an audit.

    9. Registration of audit results. Classification of identified nonconformities.

    10. Documenting the process of organizing and conducting an audit.

    11. Strategic management by top management. Analysis and improvement. Corrective and preventive actions (CAPA).

    12. Discussion of controversial issues.