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CDSCO CDSCO

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

  • Video
  • Learning Content
  • Assessment
  • Discussion Forum
  • Feedback

For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225

Assistant Nodal Officer, SAKSHAM
Dr. Raj Narayan
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 327
Email - support.saksham@nihfw.org

Department of Statistics & Demography (S&D) NIHFW, New Delhi - 110067
Website : www.nihfw.org

For NMCN related queries, contact:

Dr. Avdesh Chandra
Project Consultant, National Resource Centre, National Medical College Network, AIIMS, New Delhi - 110608
Contact - +91-9910675076, +91-9818664747
Email - nrcsetfacility@aiims.edu