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.
More articles from Damla Varol
To successfully get a drug FDA approved, the data on the drug’s effects need to be reviewed by the Center for Drug Evaluation and Research (CDER), which in turn needs to determine that the drug’s benefits notably outweigh its known and potential risk...
The final date for all MDD-certified devices to be certified under the new MDR is May 25, 2024. Once a medical device is EU MDR compliant (even prior to this date), it can be certified under the MDR. However, it is not mandatory to obtain EU MDR cert...
The skills matrix as an HR and project management tool The skills matrix is one of the core management tools to ensure your success in every project as an employee, as a team, or as a data-driven HR professional. A skills matrix – also known as a com...
Introduction to Audits An audit is the verification, inspection, or examination of a process, product, or system to guarantee compliance with regulatory or organizational requirements. The scope of an audit can apply to an entire organization or be l...
Medical Device Development Phases According to Regulations Medical device development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MDR compliance.
QA and QC processes are inseparable parts of the overall Quality Management System (QMS), and they are often used interchangeably. However, while these processes feature some overlap, it’s essential to note that they are two separate entities and tak...
A complex and multi-layered phenomenon, there is no single definition of quality culture. There are many ways to define this concept. However, the main content elements of organizational culture are summarized in Schein's definition.
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...
What is Change Management? In order to keep up with rampant globalization, manufacturers face ever-increasing pressure to produce high-quality products faster and at lower costs. They continuously need to respond quickly to meet evolving customer dem...
What is DMAIC? DMAIC is an acronym for Define, Measure, Analyze, Improve and Control. The DMAIC process is the quality improvement methodology of Six Sigma that’s used for improving existing processes. It is an integral part of a Six Sigma approach, ...
Corrective and Preventive Action (CAPA) management is a vital process of any Quality Management System. CAPAs are the necessary steps that must be taken to eliminate causes of non-conformities or other undesirable situations and lie at the heart of p...
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