Metal Impurities in Finished Drug Products

Metal Impurities in Finished Drug Products - Webinar CD/Transcript

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Metal Impurities in Finished Drug Products: Dealing with a Changing and Uncertain Landscape

The ICH is rewriting the rules on metal impurities in manufacturing — with barely any notice. Worried you’ll get caught short? Then please read on ...

Drugmakers received a nasty surprise a few months ago as the ICH proposed new rules regarding metal impurities in finished drug products. 

How to prepare for compliance in a changing and uncertain landscape? 

Luckily, FDAnews secured a top expert on metal impurities, Nancy Lewen, to explain the new guidance. In 90 information-packed minutes, she helps you understand what’s going on and how to prepare for compliance — starting now. You’ll discover:

  • Potential impacts of Q3D guidelines on drugmakers’ sourcing, testing and manufacturing processes
  • How the Q3D guidelines match up against the in-development USP 232/233 standards
  • Proven ways to make sure suppliers are up to snuff on testing
  • Risk assessment strategies for controlling elemental impurities
  • How compliance with USP water quality requirements can lower your level of elemental impurities
  • The difference between in-house vs. outsourced testing
  • And much more

The new metal impurity limits are likely to cause upheavals in quality management and in-bound materials testing departments at drugmaking facilities worldwide. Be proactive. Act now to head off regulatory tangles tomorrow.

  • Materials Sourcing Professionals
  • Supplier Management Professionals
  • Testing and In-bound Materials Professionals
  • Quality Assurance/Quality Control
  • Regulatory Affairs Professionals
  • Manufacturing Directors

Nancy Lewen is a specialist in atomic spectroscopy techniques, with more than 25 years’ experience at Bristol Myers Squibb. She is a member of the USP chemical analysis expert committee, and sits on the USP Elemental Impurities Advisory Panel as well as the USP <191> modernization and waters subcommittee. She is a recipient of the BMS Chemistry Leadership Award, and the Outstanding Women in Science Award from the New Jersey Association of Biomedical Research.