Damla Varol
QA Consultant, Scilife
With 14+ years of experience in medical device and pharmaceutical manufacturing, Damla is a QA RA Consultant known for her meticulous attention to detail and passion for quality standards. From working with the largest manufacturing companies to medical device start-ups, she has mastered ISO 9001, ISO 13485, MDD, MDR, and FDA CFR 21 Part 820 regulations. Applying her extensive expertise and skills, she offers practical compliance solutions and invaluable insights to help industry professionals achieve compliance excellence.
Quality management software is gaining traction as a dependable adjunct to quality management teams. The benefits are substantial, especially in life sciences, where quality translates to rapport and, subsequently, sales. This growing reliance on qua...
In life sciences, one of the most heard terms is non-conformity management or NC management. To utilize and maintain an ideal NC management process, first, you need to understand what it is for and what are the risks and costs if it doesn’t work prop...
In the highly regulated pharmaceutical and medical device industries an electronic Quality Management System plays a pivotal role where you can create, store, retrieve, and archive all of your company’s quality-related documents. Those activities ens...
Medicinal products and medical devices should be manufactured at a high level of quality to ensure they are fit for purpose. Manufacturers must also ensure patients are not at risk due to inadequate product quality.
While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...
Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...
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