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National Institute of Health and Family Welfare (NIHFW) National Institute of Health and Family Welfare (NIHFW)

6th RTP on Risk Based Inspections of Drugs Manufacturing Facilities

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6th RTP on Risk Based Inspections of Drugs Manufacturing Facilities

About the Course

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  • Background, Schedule M

    PDF

  • Quality Risk Management ICH Q9 and PQS- ICH Q10.

    PDF

  • Pharmaceutical water system and its qualification

    PDF

  • Qualification of HVAC System, Area Qualification of Sterile and Non sterile area

    PDF

  • Stability Study of Pharmaceutical Products

    PDF

  • Media Fill Simulation Studies

    PDF

  • Data integrity

    PDF

  • Soft skills

    PDF

  • Non compliances obsereved during Not sterile dosage form facility inspections

    PDF

  • Concepts of OOS, Change Control, Deviation and Trend Analysis

    PDF

  • GCP Inspectoin Inspection Techniques

    PDF

  • Planning, Conducting inspections based on RB approach & Writing effective inspections repo

    PDF

  • Recent advances and trends in the analytical instrumentation techniques and its applicati

    PDF

  • An overview of GLP Schedule L-1 and Analytical method Validation in Pharmaceuticals

    PDF

  • Process Validation

    PDF

  • Control on Raw Materials , packaging materials and Vendor Qualitfication

    PDF

  • Non Compliances observed during Sterile dosage Form facilities

    PDF

  • Cleaning Validation

    PDF

  • Post Assessment

    Assessment

  • Certificate

    CDSCO Certificate

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This course includes

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  • 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