Work smart: Risk based approach for cleaning validation

Work smart: Risk based approach for cleaning validation

04/19/2018, 10:30 AM - 11:15 AM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

Language:
English

The presentation will explain the impact of the changes in EU and EMA guidelines regarding cleaning validation. Following that, the presentation will deep dive on risk-based approach to be used to ensure compliance with the international cleaning regulatory. Finally, through a case study (used as an example) the presentation will present rational to develop risk based cleaning validation limit and program: (1) assess and prioritize the toxicological value, (2) assess the safe threshold value versus the cleaning process capability, (3) understand the influence of the recovery rate, LOQ/LOD of the analytical methods on setting cleaning limit, (4) when visual residue limit could be used only. The risk assessment objective is to rationalize the numbers of validations run, prioritize the workload and demonstrate effective the cleaning process in place. Finally, we will share different approaches implemented by manufacturers around the globe.

Contributors

  • Walid El Azab

    Speaker

    Technical Service Manager

    STERIS Life Science

    Walid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. - understand the regulatory requirements for cleaning validation 2. - improve and reduce number of validation runs through robust Risk Assessment 3. - understand how others companies are implementing the new requirements

Categories

  1. Track
    Manufacturing Efficiencies & Improvements

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