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CDSCO CDSCO

40th RTP on Managing Pharmaceutical Recalls: Regulatory and Industry Collaboration

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40th RTP on Managing Pharmaceutical Recalls: Regulatory and Industry Collaboration

About the Course

  • Root Cause Analysis (RCA) in Recalls: Advanced Tools (Fishbone, 5-Why, Fault Tree Analysis), Linking RCA with CAPA Effectiveness, Avoiding Repeat Recalls

    Video - Mr. Haresh Korde

  • Regulatory Requirements: India vs GlobalRecall provisions under the Drugs and Cosmetics Act, 1940 & Rules, CDSCO recall guidelines (2012 & updates),Comparison with: US FDA recall procedures (21 CFR Part 7), European Medicines Agency recall system,

    Video - Mr. Sourav Ghosh

  • Supply Chain Traceability & Digital Tools:Serialization and Track & Trace,Use of ERP Systems in Recall,Blockchain Potential in Pharma Recalls,AI Driven Re-call Signals

    Video - Mr. Bhaskar Ande

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This course includes

  • Video

For technical (platform) related queries, contact:

Dr. Dharmendra Kumar Yadav
Nodal Officer, SAKSHAM
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 341
Email - support.saksham@nihfw.org

Address

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

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