CMC Analytical Development for Biotech and Biosimilar Products: Critical Points and Common Mistakes

CMC Analytical Development for Biotech and Biosimilar Products: Critical Points and Common Mistakes

$209.00

This 2-hour webinar will provide a succinct but comprehensive overview of the regulatory and technical elements relevant to the analytical characterization and comparability of biotech and biosimilar products, as well as issues critical to setting meaningful, supportable specifications for release and stability. The 11 critical analytical studies currently required for biotech product regulatory dossiers will be illustrated, along with the 12th study necessary for biosimilar products. Finally, emerging hot-button analytical topics for new and biosimilar products will be highlighted.

Who should attend:

  • Regulatory Affairs
  • Quality Assurance and Control
  • Research and Development
  • Documentation Management
  • Product Development
  • CMC Operation
  • Technical Operation
  • Subject Matter Experts
  • All personnel who want to learn about¬†CMC Analytical Development

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