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PDA India Chapter Presents: A Two Day Interactive Workshop on Extractables & Leachables

Jul 04 - Jul 05, 2019
Hyderabad, India

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Overview

This two-day workshop will look at aspects of "Extractables and Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, and Toxicology & Assessment.

In addition, during the workshop, there will be multiple case study discussion and activities to improvise your learning experience.

Topics of discussion will include:

  • Polymers in the Sterile Drug Products - Sources & Effects
  • Regulatory requirements-US FDA/MHRA/EU/WHO/ANVISA
  • Approaches for designing studies of E&L
  • The Threshold approach and its execution-E&L
  • Analytical Techniques - The challenges in classical pharmaceutical molecules
  • Leachables studies - Design & execution
  • Selection of Closures - Points for consideration to avoid rework
  • Selection of Containers - Points for consideration to avoid rework
  • Formulation & Development Case Study for E&L
  • E&L - Single Use systems
  • Risk Assessment Techniques - Activity and the case study
  • Toxicology and assessment
  • Extractables & Leachables in Pharmaceutical Packaging/Delivery System: USP Perspective

Agenda

  • Day 1
  • Day 2
  • Thursday, July 4th

    • 9:00 a.m. - 9:30 a.m.  Introduction of PDA Inc. - PDA India Chapter
    • 9:30 a.m. - 10:20 a.m. Polymers in the Sterile Drug Products - Sources and Effects
    • 10:20 a.m. - 10:30 a.m. TEA BREAK
    • 10:30 a.m - 11: 20 a.m.  Regulatory requirements - US  FDA/MHRA/EU/WHO/ANVISA
    • 11:25 a.m. - 12:15 p.m. Approaches for designing studies of Extractables & Leachables
    • 12:20 p.m. - 1:10 p.m. The Threshold approach -Extractables & Leachables
    • 1:10 p.m. - 2:10 p.m.  LUNCH BREAK
    • 2:15 p.m. - 3:00 p.m.  E&L - Single Use systems
    • 3:05 p.m. - 3:55 p.m.  Analytical Techniques - The challenges in classical pharmaceutical molecules
    • 4:00 p.m. - 4:15 p.m.  TEA BREAK
    • 4:50 p.m. - 5:30 p.m. Panel discussion, Q & A and Wrap up
  • Friday, July 5th

    • 9:00 a.m. - 9:30 a.m.  Recap of Day 1
    • 9:15 a.m. - 9:55 a.m.  Leachables Studies - Design & Execution
    • 9:30 a.m. - 10:20 a.m. Polymers in the Sterile Drug Products - Sources and Effects
    • 10:00 a.m. - 10:15 a.m. TEA BREAK
    • 10:20 a.m - 11: 00 a.m. Selection of Closures - Points for consideration to avoid rework
    • 11:05 a.m. - 11:45 a.m. Selection of Containers - Points for consideration to avoid rework
    • 11:45 a.m. - 12:25 p.m. Formulation & Development Case Study for Extractables & Leachables
    • 12:30 p.m. - 1:15 p.m. Extractables & Leachables in Pharmaceutical Packaging/Delivery System: USP Perspective
    • 1:20 p.m. - 2:00 p.m.  LUNCH BREAK
    • 2:00 p.m. - 2:45 p.m. Risk Assessment Techniques - Activity and the Case Pharmaceutical formulation & Biotechnology Formulation
    • 2:50 p.m. - 3:45 p.m.  Strategies & Tools for the Toxicology evaluation of Extractables & Leachables
    • 3:45 p.m. - 4:00 p.m.  TEA BREAK
    • 4:00 p.m. - 4:50 p.m. Panel discussion 
    • 4:50 p.m. - 5:30 p.m. Panel discussion, Q & A, Felicitation and Wrap-up

Travel

Novotel Hyderabad Airport

Airport Approach Road
Hyderabad, India

Directions

Registration Fees

Regular Price
Registration Type Price
Member ₹20,000
Non-member ₹22,000

GST at 18% As levied by the Govt of India




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