Development of a strategy for managing the risk of cross-contamination

Development of a strategy for managing the risk of cross-contamination

Details

  • Start date: 15 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 15 December 2022
  • 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 08.12.2022) + 36 Euro for each next participant;

    200 Euro (from 08.12.2022) + 40 Euro for each next participant

     

    In a programme:

    1. Quantification of the severity of harm to the patient, carrying residues of a potent drug as cross-contamination in the composition of other drugs. Selecting an appropriate methodology for quantifying this risk.

    2. Evaluation of the likelihood of potential cross-contamination, taking into account the technical means and organizational measures already implemented in production to manage the risks of cross-contamination. Selecting an appropriate methodology for quantitative and/or qualitative assessment of this risk.

    3. Evaluation of the probability of timely detection of potential cross-contamination, taking into account the technical means available in the production and organizational measures to manage the risk of cross-contamination. Selecting an appropriate methodology for quantitative and/or qualitative assessment of this risk.

    4. Determination of measures to reduce the high level of risk of cross-contamination for the possibility of introducing a potent drug into a multi-product production.

    5. Documenting the risk assessment and making a decision on the potential possibility or impossibility of producing a potent drug at the general production facilities.

    6. Development of a strategy for managing the risk of cross-contamination in the process of introducing a potent drug in a diversified production.