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
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).
Mark Shaffer, Pharmaceutical Business Development Manager for Domino Amjet North America, shares his perspective on the DQSA, the challenges it presents for pharmaceutical manufacturers and Domino’s unique solutions, while on the floor at INTERPHEX. Stressing the key components for serialization success, Mark says finding valuable, knowledgeable partnerships is most important. Discover why he believes “Domino […]
Due to the increase in global initiatives to better secure the pharmaceutical supply chain, it is necessary to select valuable, trusted partners in order to protect your brand, bottom line and, most importantly, your customers. Domino Printing Sciences and Omega Design Corporation have partnered for more than 20 years and continue to work together, preparing […]
The Domino team enjoyed attending Case Study: Serialization Impacts in the Pharmaceutical Industry by OptelVision's Serialization Product Manager Jean-Pierre Allard at INTERPHEX 2014. Allard addressed the current global state of compliance by country, emphasized the value in aggregation systems compared to item level serialization and explained the role of IT integration, among other solutions, all […]
Hear from Domino Printing North America's Mark Shaffer on how integrated partner OEM solutions, featuring Weiler Labeling Systems and Omega Design Corporation, are key to meet the new federal legislation.
Domino is thrilled to attend the International Pharmaceutical Expo (INTERPHEX), the leading pharmaceutical and bio-pharmaceutical manufacturing trade show in the U.S. Why is this event a great fit for Domino? Because the Drug Quality and Security Act (DQSA) has been passed, it is important for industry professionals to get their serialization questions answered and ACT […]
As a result of DQSA, many are facing compliance challenges such as lack of qualified vendors, limited vendor bandwidth and time consuming implementation. Domino developed streamlined serialization solutions to be demonstrated live on the floor at INTERPHEX March 18-20, 2014 at the Javits Center in New York City. Catch the action at Booth #2725! Domino Amjet […]
Since the World Health Organization recognized the problem of counterfeit pharmaceuticals 40 years ago, the industry has waged a constant battle against sophisticated counterfeiters, with drug packaging as its foremost defense. The U.S. has passed legislation, increasing efforts to combat counterfeiters, while other countries have developed their own serialization initiatives. A fundamental premise for all […]
A recent survey conducted by Healthcare Packaging in late 2013, found serialization was the top concern among combination product manufacturers. Creative medical treatment advances including the combinations of biologics, medical devices and/or pharmaceuticals have been in development for over 20 years, and now, they’re seeking guidance in packaging and regulatory issues.
The Drug Quality and Security Act (DQSA) preempted all existing and future state pharmaceutical pedigree and serialization laws. So what does this mean for all the research and planning many have put into compliance at the state level?