Thought Leadership

Browse through this hub for company-related and Life Sciences industry news. You’ll find blogs that highlight the latest hot topics impacting quality and compliance in the Life Sciences industry, as well as Pilgrim press releases and articles by experts inside and outside the company.

Blog Posts

Reduce Product Risk, Improve Patient Safety
Kari Miller, Regulatory and Product Management Leader, IQVIA Quality ComplianceFor medical device manufacturers, patient safety is always paramount, but right now, in light of the COVID-19 pandemic, it is definitively top of mind. As such, implementation of an effective risk management program is critical to helping manufacturers determine the safety of their medical devices throughout the product lifecycle. And while risk management activities are paramount to patient safety, they are also required by regulatory and other quality management standards.
Limit the Stakes with Risk-Based Employee Training
Lynn Willis, Engagement Manager, Curriculum Development and Product Training, IQVIAEmployees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Risk-based employee training is essential to bridging the awareness gap. Since the adoption of ISO 13485:2016, Life Sciences manufacturers have continued to step up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
Distinguish Your Organization with Risk-based Supplier Inspections
Roxane Napoli, Director of Marketing Communications, US Marketing, IQVIAOptimization of your supplier quality management processes gives you room to differentiate yourself from your competitors and gain advantages in your industry. Optimization alone, however, does not happen without regard for potential risks inherent within complex supply chains or ever-evolving regulatory requirements. Your organization can distinguish itself from your competitors by circumventing potentially adverse situations before they become realities. Minimizing supplier-related risk will maximize your compliance and quality improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line.
Quantify Risk to Boost CAPA Efficiency
Kari Miller, Regulatory and Product Management Leader, IQVIA Quality ComplianceCorrective and Preventive Action (CAPA) systems provide a wealth of information regarding the quality of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is not uncommon for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole.
Quality Management and Design Control Requirements for MedTech
Todd Neal, Product Manager, IQVIA Quality ComplianceFor any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS) can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control for medical devices to ensure that specific requirements for their devices are met. Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device.
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