Laura Johnson

Laura Johnson

Laura brings over twenty years of expertise working with both Pharmaceutical and Medical Device manufacturers to improve processes and meet regulatory requirements such as Serialization, UDI and Secure Supply Chain. Laura’s career has also focused on the application of technology to drive efficiencies in manufacturing, warehousing and distribution environments. Her expertise includes leveraging core functionality within major ERP systems like SAP and Oracle and implement automatic data capture technologies such as vision inspection, printing, shop floor devices, barcode and RFID data collection.

Recent Posts by Laura Johnson:

by Laura Johnson, on January 18, 2017

If your healthcare organization collects blood or blood components for transfusion, the FDA has some new recommendations for labeling that you’ll want to check out. Just recently the Administration announced …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on October 27, 2016

Member states of the European Union (EU) have just a few days left to adopt standardized labeling for donor tissue and cells. October 29th is the deadline for EU countries …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on September 27, 2016

Medical device labels need to be easy to read - a challenge for some device makers. In order to meet the September 2016 UDI deadline, medical device manufacturers must label …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on September 8, 2016

This past week, the FDA announced that as part of its Opiods Action Plan it is "requiring class-wide changes to drug labeling." The changes are being enacted to help inform health care providers and …

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Topics:Pharmaceuticals

by Laura Johnson, on April 22, 2016

It's been three years since the U.S. Food and Drug Administration mandated unique device identification for most medical devices distributed and used in the U.S. How has the process unfolded so …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on April 6, 2016

The market for counterfeit drugs endangers consumers and costs the pharmaceutical industry billions of dollars in lost revenue each year. This market is growing. Decentralized pharmaceutical manufacturing and increasing global …

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Topics:PharmaceuticalsLabeling

by Laura Johnson, on March 30, 2016

Next year, pharmaceutical distributors will be required to comply with new track-and-trace requirements. Under the DSCSA, they'll have to report the chain of custody of each individual drug. The rules …

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Topics:PharmaceuticalsRegulatoryLabeling

by Laura Johnson, on March 24, 2016

The 4th Annual Pharmaceutical Labeling Compliance event, held last week in Boston, brought together nearly 100 professionals involved in the packaging and labeling in pharmaceuticals. Many of the sessions focused on …

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Topics:Pharmaceuticals

by Laura Johnson, on March 23, 2016

Pharmaceutical counterfeiting costs the industry billions of dollars per year, and threatens the health of millions of consumers. Cracking down on this practice is of paramount importance for manufacturers. Criminals …

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Topics:PharmaceuticalsLabeling

by Laura Johnson, on March 16, 2016

Beginning on March 1, a delayed provision of the Drug Supply Chain Security Act will finally go into effect. Pharmaceutical dispensers will be required to conduct lot-level product tracing, which …

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Topics:PharmaceuticalsLabeling

by Laura Johnson, on March 11, 2016

Labeling experts at this year's 4th Annual Pharma Labeling Compliance Event will offer insights on ensuring consistency and compliance for global labeling requirements. Laura Johnson, labeling expert from Loftware, the global leader …

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Topics:PharmaceuticalsRegulatory

by Laura Johnson, on March 9, 2016

New provisions of the FDA's UDI regulations will be going into effect in September 2016. But that doesn't mark the end of the work that medical device manufacturers will have to …

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Topics:Medical DevicesRegulatoryLabeling

by Laura Johnson, on March 4, 2016

I had the pleasure of attending the 8th Annual Pharma Packaging and Labeling Conference last week in Philadelphia, and it really underscored the importance of enterprise labeling from both a regulatory …

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Topics:PharmaceuticalsLife SciencesRegulatory

by Laura Johnson, on March 1, 2016

In 2013, the U.S. Food and Drug Administration finalized its UDI rule, requiring medical device manufacturers to bear labels containing device identifiers and production identifiers. Initially, the rule established a …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on February 22, 2016

We’re excited to be first-time exhibitors at the annual HDMA Distribution Management Conference (DMC), March 6 – 9, in San Antonio, Texas. As the leading provider of Enterprise Labeling Solutions …

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Topics:PharmaceuticalsMedical DevicesLife Sciences