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Rebecca Beausang
Regulatory Affairs Specialist, Scilife
Rebecca has over seven years of experience in medical device and other regulated industries. Alongside her expertise in FDA submissions, EU MDR compliance, and ISO 13485 QMS implementation, Rebecca is skilled in creating clear and impactful regulatory content. From technical documentation to compliance blogs, she excels in translating complex topics into engaging, actionable insights. Her passion lies in using compliance as a strategic tool to drive innovation and trust in regulated markets.
If you're in pharmaceutical development, Quality by Design (QbD) is a term you know well. It represents an advancement in how we develop and manufacture medicines, and at its heart is the ICH Q8 guideline.
I’m willing to bet you’re here because of a specific incident. Maybe it was during a batch record review, you saw a signature next to a step that you know, for a fact, was not performed correctly.
In my years working in quality, I’ve learned a few things that cause more anxiety than an upcoming audit of a newly qualified piece of equipment. That's why having a solid grasp of IQ OQ PQ: Installation Qualification (IQ), Operational Qualification ...
In the life sciences industry, a robust Quality Management System (QMS) is all-important for achieving compliance, sustaining operational efficiency, and safeguarding public trust. A QMS underpins every aspect of quality control, from adhering to str...
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