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.
A well-trained workforce is vital for the quality and safety of a product, particularly in the pharmaceutical industry, as well as other industries with strict regulatory requirements. Being “well-trained” means employees don’t just go through the mo...
In the medical device industry, there are tons of abbreviations. And as a medical device professional you can easily get lost in this acronym ocean! The most important (and most confusing) abbreviations are DHF, DMR, and DHR. These three abbreviation...
Artificial intelligence (AI) and machine learning (ML) are on the verge of transforming healthcare by creating new, vital insights from the vast amount of data gathered during healthcare delivery activities every day. AI/ML-based life science innovat...
The life science industry, including pharma, biotech, and medical device companies, churn out tens of terabytes of data every single day.
Over the past few years, the life science industry has undergone meaningful growth and change. So what should you expect in 2023? The pharmaceutical and med-tech industries have adapted, innovated, and are expected to undergo a sea of change in the y...
Deviations and nonconformities, as all QA professionals know, are at the very heart of quality management. Detecting them is fundamental in preventing quality issues, and paves the way to improvement. However, preventing deviations and nonconformitie...
Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...
The objective of a QMS is to define and formalize a system that documents processes, procedures and responsibilities for achieving quality policies and objectives. It basically provides the structure for various functions within an organization to wo...
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