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Latest Posts by Christelle Laot

January 7, 2015

Struggling to comply with DSCSA for prescription drugs? FedEx TranSmart® can help!

Many regulations and initiatives worldwide aim at further securing and controlling the complex supply chain of healthcare shipments. The US Drug Supply Chain Security Act (DSCSA), also known as Title II of the Drug Quality and Security Act (DQSA), was signed into law on November 27th, 2013. It represents a staggered approach towards serialization, and electronic track-and-trace for human prescription drugs in finished dosage form.

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June 2, 2014

Validation versus Qualification in Shipping

Many healthcare shippers ask us at FedEx Express whether our cold chain transportation solutions are validated.

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February 13, 2014

Flowers or Chocolate – Quantifying Business Value

As we get close to Valentine’s Day, many of you may be wondering what to buy for your loved ones: flowers or chocolate?

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January 8, 2014

Risky Business

This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks.

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October 7, 2013

A Hot Topic: Innovative Aircraft Temperature Controls

Pharmaceuticals and biotechnological products are often produced in one region of the world and sold in another. 

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August 6, 2013

FedEx Qualified!

Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.

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