Coding for Compliance
This blog is a central resource for coding and pharmaceutical compliance issues. After 20 years in the market, I appreciate the challenge of gathering information and finding a forum to discuss key issues. I developed this blog to support these efforts in the pharmaceutical industry. Let’s start a dialogue.
Pharmaceutical Business Development Manager, Domino
The FDA recently released new guidance as the first in a three-part series for implementation of the Drug Quality and Security Act (DQSA). The new US legislation mandates that by 2015, any trading partner who suspects counterfeit drugs within the pharmaceutical supply chain is required by law to notify the FDA.
Jack Tarkoff, vice president of sales for rfXcel, recently published the article, “DQSA Is the Antidote for Fragmented State-to-State Legislation” in Supply and Demand Change Executive. Tarkoff provides an in-depth examination of the DQSA explaining requirements, deadlines and implementation. But refreshingly, before concentrating on all the diverse elements encompassing the “how” of serialization, he reminds […]
Domino printing partnered with leading Track & Trace software provider Optel Vision to host a two-day seminar at this year's Interpack Expo. The presentation topic was serialization and the primary message of urgency was clear. "If you don’t plan ahead, it could be catastrophic," warned Bart Vansteenkiste, EU Lifesciences Sector Manager for Domino. He and […]
Optel Vision is a leading provider of vision inspection tools and Track & Trace software and operates more than 20 countries. With a strong focus on accuracy and patient safety, Optel Vision consistently selects Domino as a trusted partner for reliable coding and marking solutions. Integrated, the two systems can provide the complete track and […]
Pharma IQ recently released an industry report detailing the findings from their latest survey, Pharmaceutical Serialisation & Traceability 2014. The survey, focusing on serialization readiness, was conducted in March of this year and targeted professionals working in pharmaceutical and biotech companies (many who work in the supply chain). Highlights show many commonalities in how this […]
Since the Drug Quality and Security Act (DQSA) was passed into law, many prescription drug manufacturers are questioning, “Does MY drug have to follow DQSA regulations?” Healthcare Packaging Contributing Editor Dirk Rodgers advises, “Only YOU can answer that question.” By carefully reading Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), anyone […]
Serialization, QRM, China and other emerging market, recent U.S. court rulings, issues with generics and more … 2014 promises to be a year of recovery and big changes in the pharmaceutical industry. Bikash Chatterjee, President and CTO, Pharmatech Associates outlines his thoughts on what we can expect in the coming months and beyond.
There should be no doubt about the breadth and depth of pharmaceutical counterfeiting around the world. Every day lives are put at risk due to counterfeit pharmaceuticals making their way into the supply chain. Just how much the U.S.’s Drug Quality and Security Act (DQSA) legislation will do to mitigate this illegal activity remains to […]
Recorded live on the floor at INTERPHEX 2014, Life Science Connect (LSC) radio hosts Todd Youngblood and Todd Schnick interviewed Domino Pharmaceutical Business Development Manager Mark Shaffer to address some of the biggest questions surrounding serialization. Listen in to learn more about Mark, his credentials and Domino’s specialties and products. Plus, get his expert perspective on […]
Items don’t move as single units, but in batches on pallets or in cases. Keeping track of what is included inside the secondary and tertiary level of packaging is the next major challenge for the pharmaceutical industry. Aggregation is about understanding how to accurately record serialized pack data and build that into a hierarchical structure […]
Domino Business Development Manager Mark Shaffer has been following serialization and its impending impact on the pharmaceutical industry for years in anticipation of the time when legislation would become a reality. With the recent passing of the DQSA, his valuable insight has served as a refreshing relief amidst swirling frustration and confusion, particularly to those […]
Around the globe and around the countries and communities in which we operate, Domino makes it a priority to be a good corporate citizen. We encourage and support volunteering and charitable donations and do everything possible to respect human rights (and we expect our suppliers to as well).