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NIHFW NIHFW

Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

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Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

About the Course

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  • Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

    Background, Schedule M

    Quality Risk Management ICH Q9 and PQS- ICH Q10.

    Pharmaceutical water system and its qualification

    Stability Study of Pharmaceutical Products

    Media Fill Simulation Studies

    Data integrity

    Soft skills

    Concepts of OOS, Change Control, Deviation and Trend Analysis

    GCP Inspection Techniques

    Process Validation

    Cleaning Validation

  • Post Assessment

    Assessment

  • Certificate

    CDSCO Certificate

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This course includes

  • PDF
  • Assessment
  • Certificate

For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225
Email - drdkyadav@nihfw.org

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

Address

Department of Statistics & Demography (S&D) NIHFW, H52G+C6X, Baba Gang Nath Marg, Block A, Munirka, New Delhi, Delhi 110067
Website : www.nihfw.org