• The Difference Between Regulatory Operations And Regulatory Affairs

    Just as we need experienced air traffic control specialists to ensure safe airplane travels, life sciences companies need experts who can navigate the inherent complexities of interactions with regulatory authorities who authenticate the safety of products on the market. This blog provides a better understanding of regulatory operations professionals’ objectives and needs  providing insight into the tremendous impact they have on regulated product developers’ successes or failures.

  • Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

  • Contamination Control Strategies For Pharmaceutical Manufacturing Environments

    Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.

  • Life Sciences Quality And Compliance Software Product Demonstration

    MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. The MasterControl Platform helps organizations digitize, automate, and connect quality and compliance processes across the regulated product development life cycle.

  • How To Stay Ahead Of Disruptive Trends In Clinical Trials

    Clinical trials are evolving. Whether it’s disruptive technology, changing regulations, or external factors. The pace of change is only increasing - along with the complexity of ensuring your trial data is secure and compliant. This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.

  • What Are GxPs And How Do They Shape The Quality Of Your Pharmaceutical Product?

    Understanding and following GxPs helps to mitigate crucial business risk and improve product quality. Pharmaceutical companies should apply GxPs and the best scientific technology in their quality management systems.

  • Overcoming Pharma’s Top 6 Quality And Compliance Oversights

    For companies doing business in the heavily regulated pharmaceutical industry, quality management and compliance are not just intimidating endeavors — they involve activities that are increasing in complexity as the industry accelerates. This article presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time. It also recommends actions organizations can take today to help mitigate the long- and short-term problems caused by each oversight.

  • What You Need To Know About Manufacturing OTC Products

    As more medications move to OTC status, people are interested in playing a more active role in managing their health and controlling their healthcare choices. However, self-medication comes with risks.

  • Container Closure Integrity: A Risk-Based Approach To Ensure Drug Product Quality

    Container closure integrity is essential to protect the drug product through shelf life and to demonstrate an integral system to regulatory agencies. A proper risk-based approach enables creation of a robust data file that can assist in the timely approval of regulatory applications.