Practical application of the concept of risk in the planning and implementation of pharmaceutical development

Practical application of the concept of risk in the planning and implementation of pharmaceutical development

Details

  • Start date: 01 February 2023
  • Start time: 10:00 (Kyiv)
  • Finish date: 01 February 2023
  • Finish time: 14:00 (Kyiv)
  • Duration: 1 day, 4 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    180 Euro (pre-sale until 03.11.2022) + 36 Euro for each next participant;

    200 Euro (from 03.11.2022) + 40 Euro for each next participant

     

    At the heart of the online seminar:

    — risk management methodology;

    — the relationship and differences of risks in pharmaceutical development, transfer and validation of a serial production process;

    — personal experience and practical solutions.

     

    In a programme:

    1. We will look at risk management techniques in the pharmaceutical development phase:

    • Identification of risks by product and process;

    • Risk assessment;

    • Risk ranking;

    • Organization and participants of risk management at stages from pharmaceutical development to validation of a serial technological process.

    2. We will evaluate and analyze the relationship between risk analysis concepts for different stages of pharmaceutical development (from laboratory to transfer) and analyze the relationship with process validation.

    3. We will analyze the use of pharmaceutical development materials in planning and conducting the validation of the technological process in production and in the preparation of a validation master plan for technological processes.

    4. Consider an example of using the concept of risk analysis for the laboratory stage of pharmaceutical development in practice.

    5. Discuss the risks of process or product changes requiring the application of pharmaceutical development steps.