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

15th RTP on GMP of Parentral and Sterile preparation
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15th RTP on GMP of Parentral and Sterile preparation

About the Course

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  • Introduction to GMP and Regulatory Guidelines

    PDF

  • Facility Design and Layout for Good Manufacturing Practices Compliance

    PDF

  • Documentation and Record Keeping

    PDF

  • Stability Studies

    PDF

  • Non Compliances Observed in Parenteral and Sterile Preparation

    PDF

  • Process Validation

    PDF

  • Media fill Validation

    PDF

  • Recent Advances in Analytical Instrumentation Techniques

    PDF

  • Validation of Lyophilizer

    PDF

  • Clean in place(CIP) Sterilization in Place (SIP) of Simple and Complex Injections

    PDF

  • Pharmaceutical water for parenteral & sterile prepration and qualification & validation of water system

    PDF

  • Concepts of OOS, Change control, Deviaition and trend Analysis

    PDF

  • Primary Packaging Material for prenteral and Sterile preparations

    PDF

  • HVAC System for parenteral & Sterile Prepration

    PDF

  • Planning Conducting inspections based on risk based approach writing effective inspection reports

    PDF

  • Validation of Sterilization process

    PDF

  • Post Assessment

    Assessment

  • Certificate

    CDSCO Certificate

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This course includes

  • PDF
  • Assessment
  • Certificate
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For technical (platform) related queries, contact:

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

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H52G+C6X, Baba Gang Nath Marg, Block A, Munirka, New Delhi, Delhi 110067
Website : www.nihfw.org

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