How Compliant Is Your Company With The FDA?

Staying compliant with regulations in the pharmaceutical industry is a constant battle. Many organizations struggle to adapt and stay ahead of the constant changes and updates, including the most recent deadline of FDA’s Drug Supply Chain Security Act (DSCSA) back in November. Even the companies that have met the deadline are still being faced with hurdles to overcome in pharmaceutical labeling. It’s a significant endeavor when so many functional areas—packaging, manufacturing, distribution, labelling, artwork and IT—must work together to deliver a seamless, well-orchestrated system that meets the FDA's DSCSA requirements and keeps product moving swiftly through the supply chain.

Fortunately, the 10th Annual Pharma Packaging and Labeling East Coast event, on Feb 21-22 in Philadelphia, will tackle many of these issues facing pharmaceutical companies. This year’s agenda showcases topics around how organizations can manage regulatory demands while safeguarding products and protecting patients. Leading companies, like Bayer, Sanofi, and Janssen will review end-to-end labeling strategies for ensuring that companies are inspection ready. In addition, the Drug Enforcement Administration will be returning, offering an opportunity to hear a different perspective on ways that pharma can serve the public health.

If you are attending, be sure to sit in on Wednesday, 21st at 4:15 as Loftware’s Josh Roffman and Joe Farrell outline how innovations in Enterprise Labeling Solutions is helping pharmaceutical companies not just comply with the FDA’s DSCSA and 21 CFR Part 11 regulations, but deliver measurable gains in supply chain efficiency. By integrating labeling tightly with SAP, Oracle and other enterprise applications, customers ensure label accuracy, keep up with changing requirements, and reduce operational costs.

For those who aren’t attending, we encourage you to check out a recent customer webinar “How Perrigo Optimizes Barcode Labeling Across its Supply Chain” where you’ll learn how this industry leader is able to centralize and streamline operations with SAP barcode label integration. You'll see how this solution enables Perrigo to adapt to changing label requirements while maintaining regulatory compliance.

And don’t hesitate to contact our pharmaceutical specialists to help turn your specific pharma barcode labeling challenges into real opportunities for you.



Laura Johnson

Posted By 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.

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