IPAC-RS

IPAC-RS Supplier and Pharma Workshop on Device and Container Closure System Quality

IPAC-RS Supplier and Pharma Workshop on Device and Container Closure System Quality

Working Group:

OINDP Materials

The IPAC-RS OINDP Materials Working Group hosted an IPAC-RS Supplier and Pharma Workshop on Device and Container Closure System Quality on November 8, 2018 in Washington, DC.  The Workshop goals were:  1) to discuss and obtain feedback on the concepts and application of the IPAC-RS Baseline Requirements document, 2) identify areas where IPAC-RS, in partnership with suppliers, may drive forward activities of value to both product manufacturers and the supply community, and 3) educate and share knowledge on what it takes to ensure material and component quality.

  1. Setting the stage - Presented by Gaby Reckzuegel, Boehringer Ingelheim
  2. Introduction to the VDI (Verein Deutscher Ingenieure) guideline on Medical Grade Plastics, by the Association of German Engineers - Presented by Christian Pommereau, Sanofi
  3. Review Considerations: Biocompatibility Assessment of Nasal Spray Devices - Presented by Sarah Mollo, CDRH, FDA
  4. Regulatory Perspectives on Application of ISO 18562 Standards - Presented by Elizabeth Katz, CDRH, FDA
  5. Impact of New Requirements for Suppliers - Presented by Peter Claessens, Amcor
  6. Novel applications and product designs:  driving new requirements for assessment and selection - Presented by Barbara Falco, Bfalco Pharma LLC
  7. USP-NF Packing Standards Update - Presented by Cheryl LM Stults, USP Packaging, Storage Committee
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