SERIALIZATION FEATURED ARTICLES
Three Questions To Consider For DQSA Readiness
By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory
Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.
SERIALIZATION WHITE PAPERS & CASE STUDIES
Pharmaceutical Product Traceability Achieved With 2-D Barcode Reading
Within the pharmaceutical industry, stringent legislation exists to combat counterfeit goods by ensuring each product can be traced throughout the supply chain. In order to achieve the required levels of traceability, manufacturers are increasingly reliant on printed 2-D codes combined with advanced code reading technology.
10 Reasons To Choose Image-Based Barcode Readers
Image-based barcode readers are rapidly replacing laser scanners in a wide range of industries including food, beverage, consumer goods, pharmaceutical, and logistics, but when considering a transition from laser scanners to image-based barcode readers many think the investment cost is too high.
Serialization And The Drug Quality & Security Act: A Top-Down Synergistic Approach
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA).
SERIALIZATION PRODUCTS & SERVICESMore Serialization Products & Services
LIFE SCIENCE WEBINARS
Common Misconceptions in Freeze-Drying: Part Two
This is the second of two presentations addressing some of the most common misconceptions in freeze-drying (lyophilization) relating to formulations, process cycles, equipment and scale-up.
Overcoming Analytical Method Development Challenges: Analysis Of Nonclinical Dose Formulations From hERG Studies
This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
Delivering Biologics With A Difference
In this webinar you will learn about delivering intravenous-dosed biologics in an aseptically-filled intravenous bag and increase your understanding of the business drivers and potential value added with this strategy.
Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate Governance
In this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.