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About

Ensuring quality, safety, and regulatory compliance for drugs and biologics.

Starts

Nov 13, 2018

Ends

Nov 14, 2018

This conference will provide comprehensive coverage on:

  • Implementing USP <232> and <233> and ICH Q3D: Updates and Case Studies
  • The Ongoing Development of USP Chapters <665> and <1665> Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems
  • Injectables Drug Product Long Term Leachable Study
  • Approaches and Regulatory Expectations – an Industry-wide Survey
  • Case Study and Experience on Sanofi’s implementation of BPOG’s Leachable Risk Assessment Model
  • Toxicology Issues in Extractables and Leachables
  • Analytical Challenges in E/L Studies of Pre-Filled Syringes for Oil-Based Drug Formulations
  • Extractables & Leachables Studies on Single-Use Components in Biomanufacturing
  • Advanced Identification Methods for E/L from Packaging & Manufacturing Components
  • Streamlining GC/MS and LC/MS Workflows for Extractables Profiling and Leachables Testing
  • USP <661>, USP <661.1>/<661.2> : A Review of Compendia Based Polymer Extractable and Chemical Safety Assessment
  • Use of Chemical Characterization and Risk Assessment of Medical Devices to Design Biocompatibility Testing Plans and Explain Test Results

Meet SGS expert Dujuan Lu to discuss your upcoming E&L project needs.