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NIHFW NIHFW

Risk based inspection of the manufacturing facilities

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Risk based inspection of the manufacturing facilities

About the Course

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  • Lesson - Background, objective and expected outcomes of training

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  • Lesson - 2 SCHEDULE M Good Manufacturing Practices

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  • Lesson - 3 Qualification of HVAC System, Area qualification (Sterile area & Non-sterile area)

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  • Lesson - 4 Pharmaceutical Water System & It's Qualification

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  • Lesson - 5 QUALITY RISK MANAGEMENT

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  • Lesson - 6 Stability Study of Pharmaceutical products

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  • Lesson - 7 Aseptic Process Validation Media Fill Simulation

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  • Lesson - 8 DATA INTEGRITY

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  • Lessson - 9 Cleaning Validation

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  • Lesson - 10 Sanofi Presentation

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  • Lesson - 11 RBI-Inspection Tachniues

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  • Lesson - 12 Planning conduting inspections based on Risk based approch & Writing effective inspection reports

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  • Lesson - 13 AN OVER OF GOOD LABORATORY PRACTICES SECHEDULE L-1

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  • Lesson 14 - Recent advances and Trends in Analytical Instrumention Technique and It's application

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  • Lesson 15 - VENDOR MANAGEMENT

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  • Lesson 16 - Process validation life cyle approach

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  • Lesson - 17 Non Compliances observed during Non-Sterile dosage form facility inspection

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  • Lesson - 18 NON COMPLIANCES OBSERVED DURING STERILE DOSAGE FORM FACILITY INSPECTION

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  • Assessment

    Check Your Knowledge

  • Discussion Forum

    Discussion Forum

  • Feedback

    Feedback

  • Certificate

    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