Evaluating Risk in the Pharmaceutical Supply Chain "Middle Miles"
Evaluating Risk in the Pharmaceutical Supply Chain "Middle Miles"

Evaluating Risk in the Pharmaceutical Supply Chain "Middle Miles"

Webinars

14 May 2019

On Demand

Join our LIVE WEBINAR presented by Geoff Glauser, Consultant - SME - Biological Supply Chain, (BARDA), US Government - Health & Human Services; and Sumeet Singh, President, Five Rivers Rx; and David Hart ,Sr. Quality Assurance Manager, AmerisourceBergen.

Site-to-site shipments for manufacturers are pretty well controlled, or at least they should be. Greater challenges arise when product ownership changes hands, further downstream in the "middle miles" with distributors and pharmacies. It can be uncertain how to make quality decisions without full historical information. This session will examine what controls are in place in the "middle miles"; how manufacturers view and mitigate risk in the "middle miles"; and how regulations and inspections evolving GDP activities in the middle to last miles.

Learn:

  • Regulations in US vs. Canada vs. International vary for distributors to qualify pack outs and temperature control operations
  • State requirements for distributor’s quality control of facilities and outgoing shipments and DSCSA requirements for return methodologies
  • How Accreditation (NCDQS / VAWD) is affecting processes/quality in the middle/last miles
  • Manufacturers approaches to evaluating and mitigating risk in the commercial supply chain last miles
  • As US regulatory inspection and enforcement activities change, is this an opportunity for pharma to demand QA agreements and visibility into the middle to last miles.

 

 

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