Supplier and CDMOs
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For Biomanufacturers
  • How to select, qualify and manage your material suppliers and CDMOs

  • Supplier questionnaires, audits and oversight

  • Supply chain security, COGS, and alternate sourcing

  • Material and Supplier change management and comparability

For Suppliers and CDMOs
  • Manufacturer expectations on suppliers' quality standards, facilities, controls and documentation

  • Contents and expectations for CoA, CoO and other standard certificates

  • Validation documents, regulatory support files and DMFs

  • Analytical methods

  • Incoming material controls and supply chain requirements