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Kandungan disediakan oleh Tory Cenaj. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Tory Cenaj atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
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Why Do Technology Standards Matter and How Are They Being Implemented

22:31
 
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Manage episode 453208312 series 3472284
Kandungan disediakan oleh Tory Cenaj. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Tory Cenaj atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

Why Do Technology Standards Matter and How Are They Being Implemented

  • Christiane Wirrig, PhD | Customer Success Manager, Spherity
  • David Kessler | Co-owner and President, Legisym

Discussion on the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA).

Key topics

  • What is DSCSA?
  • What does FDA’s Stabilization Period mean?
  • Why do technology standards matter and how are they being implemented, i.e. interoperability through standards?
  • Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain
  • Inspections will keep happening
  • ATP is mandatory, authentication & authorization
  • Data security
  continue reading

252 episod

Artwork
iconKongsi
 
Manage episode 453208312 series 3472284
Kandungan disediakan oleh Tory Cenaj. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Tory Cenaj atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

Why Do Technology Standards Matter and How Are They Being Implemented

  • Christiane Wirrig, PhD | Customer Success Manager, Spherity
  • David Kessler | Co-owner and President, Legisym

Discussion on the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA).

Key topics

  • What is DSCSA?
  • What does FDA’s Stabilization Period mean?
  • Why do technology standards matter and how are they being implemented, i.e. interoperability through standards?
  • Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain
  • Inspections will keep happening
  • ATP is mandatory, authentication & authorization
  • Data security
  continue reading

252 episod

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