Parenteral Supply Chain

Parenteral Supply Chain
CAROLYN WILLIAMSON
Indianapolis, IN
Ph: 3152561048

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Project Integrator for Distribution Testing

Using an approved outside testing lab, we act as the project integrator for thermal packaging design, qualification, transport simulation and thermal profile analysis. We can provide all or part of any of the following services:

  • Onsite at shipping and receiving sites as well as testing lab
  • Project Management – managing meetings, minutes and timelines
  • Generate Process Map and User Requirements (product and functional)
  • Author protocols, review data and author final reports
  • Tech transfer to shipping site including SOP review and training
  • Able to fully assist in onsite performance qualification activities
  • Support integrating into a continuous verification program

Auditing

  • Audit test labs for certification to ISTA Standard 20
  • General facility compliance audits in the scope of distribution operations and testing

Staff Augmentation

  • Add staff to your team when additional skills are required.
  • Fill gaps with specialized staffing services reducing the cost of acquiring new skills under aggressive timelines.

Other Consulting Services

  • Development of standard operating procedures
  • Establishment of a Transport Qualification Program
  • Includes the creation of overall program (your Tool Box) and the development of each Tool (Risk Assessment, Templates, Change Control, etc)
  • Establishment of a Product Transport Qualification Program
  • Introducing New Technology