<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

In the context of the EU medical device regulation (EU MDR), what is an “economic operator” and why is it important for medical device manufacturers to understand the roles of economic operators? What is the difference between “placing on the market” and “making available on the market,” and why is that important? The term “economic […]

Process capability—the measure of how well a manufacturing process consistently produces products that meet specifications—is solidly in focus in FDA inspections of medical device manufacturers. Issues with process capability and the manufacture of defective products are proving not to be ends unto themselves in agency inspections, but clues that point investigators to other areas where […]

Common issues found during agency inspection of cleaning programs and cleaning validation at medical device manufacturers include choice of the wrong worst case device for validation studies, introduction of contaminants during the cleaning process, inappropriately selecting “visually clean” as a cleaning endpoint, and a lack of understanding of cleaning load size and tank cleanout frequency. […]

The regulatory framework outlined in EU Medical Device Regulation (EU MDR) Article 117 to bring drug-device combination products to market remains subject to interpretation. Key stakeholders including manufacturers, notified bodies, and regulators continue using their own perspectives to interpret the framework and how it can be used to bring combination products to market in a […]

When a device manufacturing deviation happens, key areas that can be problematic during the investigation into root cause include the scope, use of appropriate statistical methodology, and inclusion of all shared processes, equipment, and procedures, according to FDA investigators. Also challenging is putting plans in place to prevent recurrence of the deviation using the firm’s […]

Unlike in business or engineering or medicine, advanced degrees and training in the science of manufacturing quality are not available. Yet product quality is of fundamental importance to drug companies, their patients, and the institutions that regulate them. [Related: Interested in more from author Jerry Chapman? Download our latest FREE report featuring this and three […]

After the United Kingdom officially left the European Union at the end of 2020—the so-called Brexit event—its Medicines and Healthcare products Regulatory Agency (MHRA) was no longer a member of the European Medicines Agency (EMA) and needed to develop and assert an independent identity as the regulator of product registration and quality in the United […]

Is your company’s quality management system (QMS) proactive or reactive? Does your company use data, predictive analytics, statistics, process capabilities, and other tools to help reduce quality anomalies that in the past have led to complaints and other issues? Or does it only react and make changes to the QMS when issues and crises arise? […]

The pharmaceutical industry has been criticized for being slow to adopt new technology, with a tendency to continue to use antiquated methods and processes when newer ones are available. Many industry leaders attribute this lack of forward thinking to financial and product launch risk models and the burdens of being heavily regulated. Other industries in […]

The importance of data integrity and the idea of quality culture—what it is and how to measure and promote it—have been important topics in the dialogue within the pharmaceutical industry and with its regulators for several years. An important question that needs to be explored further is how efforts can promote both and be synergistic. […]