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Risk Based Inspections of Drugs Manufacturing Facilities from 16 to 21 January 2023
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Risk Based Inspections of Drugs Manufacturing Facilities from 16 to 21 January 2023

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  • Risk Based Inspections of Drugs Manufacturing Facilities from 16 to 21 January 2023

    Background, Objective and expected outcomes of training

    Sch-M(GMP)-Objectives and Components

    Qualification of HVAC System

    Pharmaceutical water system and its qualification

    Quality Risk Management ICH Q9 & Pharmaceutical Quality System- ICH Q-10

    Stability study of Pharma products

    Media Fill Simulation Studies

    Data Integrity

    Cleaning Validation

    Concept of OOS, Change Control, Deviation and Trend analysis

    GCP Inspections-Inspectoin Techniques

    Planning, Conducting inspections based on RB approac & writing effective inspection report

    softSkills

    Recents Advances and Trends in the Analytical Instrumentation techniques and its applicati

    Analytical Method Validation and Schedule L1

    Control on Raw Material Packaging Material and Vendor Qualification

    Process validation

    Non Compliances during Non Sterile Dosage Form facility inspection

    Non Compliances observed during Sterile dosage form facility inspection

  • Certificate

    Certificate

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This course includes

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  • Certificate
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