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What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - FDA Guidance Documents, ISO and USP considerations.
On June 18, at 11 a.m. ET, West experts Daniel Bantz and Jenifer Riter will present a free webinar as part of the Navigating the Changing Regulations series, “Demystifying Performance Testing: Strategies to Qualify Combination Products.”
Jen and Daniel will explain how fit-for-purpose syringe-based combination products involve holistic consideration for:
Attendees will learn how assessing product risks early and continuously is critical to help ensure successful product development and patient safety. In addition, Daniel and Jen will discuss FDA draft guidance: Technical Information … (ISO) Standard 11040-4, which was designed to ensure syringe connection integrity to reduce potential for patient harm, and how assessing product risks properly, early and continuously is critical to help ensure patient safety.
Register now and visit our Analytical Services web pages to learn more about Packaging and Device/Combination Product Testing.
West is thrilled to announce that Thaisa Silvestre, Director, Sales, Brazil, was recently named as 2019 HBA Rising Star.
On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.
Nurturing a culture of philanthropy and community involvement is one of the defining characteristics of West. Team members around the world take their responsibility to give back very seriously, donating considerable time and resources to help create a healthier world. West without Borders, our team member-led giving programme, has raised millions of dollars since its inception in 2004 and the initiatives in Ireland were recently recognised at the Pharma Industry Awards for Corporate Social Responsibility Programme of the Year.
In March, West presented the Sri Shankara Cancer Hospital with a donation at the opening of West Digital Technology Center (DTC) in Bengaluru, India. These funds will support patients who need financial assistance and who would otherwise not be able to afford their cancer treatment.
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
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