Published Articles
Quality Culture Benefits All
Regulatory Compliance Associates® (RCA) Distinguished Fellow, Susan Schniepp discusses establishing a quality culture from the top of an organization down. Quality culture is a patient-focused approach to quality that is...
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Published Articles
Aseptic Technique & Risk Assessment
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic technique during processing. Recently, the facility has experienced an increase in the...
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Podcasts
DHF & Design Control
In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk...
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Published Articles
Emerging Therapies
Click now to listen to Regulatory Compliance Associates' executive principal consultant, pharma and biologics, Steven J. Lynn, MS, shares his thoughts about emerging therapies, expanding cell and gene therapies on...
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Visual Resources
Design History File Info Sheet
From Launch to Lifecycle, RCA can support your Design History File We offer expertise in helping you navigate through new product development and remediating legacy Design History File (DHF) files...
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Published Articles
QA Outsourcing
In today's competitive business environment, life-science companies run lean, particularly in terms of personnel. The quality assurance (QA) function creates complexity for pharmaceutical companies because need and cost vary depending...
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