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
GMP stands for “Good Manufacturing Practices.” In the realm of manufacturing, a buzzword you'll often hear is "Good Manufacturing Practices," commonly known as GMP. What exactly does it entail? This piece will outline the five main components of GMP ...
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...
Corrective and Preventive Action (CAPA) is an essential component of quality management in the pharmaceutical and medical device industry. However, problems with the CAPA process can lead to regulatory action, product recalls, and, most importantly, ...
Every year, the FDA issues hundreds of warning letters along with inspections of manufacturing facilities. You should take the warning letters seriously because they act as a precursor to a worse failure. You should always take proper corrective and ...
Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why Quality professionals in the pharma industry actively seek to understand the details of cGMP regulations. In most cases, they also...
Like any other regulated product, your medical device must be properly labeled. But do you know how to prepare a medical device label and which regulations your label has to comply with? And how about which ISO standards can help you meet these regul...
The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to learn mor...
In addition to meeting rigorous safety requirements, medical device manufacturers must also comply with strict quality standards. That is why a compliant Quality Management System (QMS) is fundamental to any Life Sciences company operating in the tig...
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...
How much do you know about Medical Device Coordination Group Documents? You may be more familiar with their abbreviation: MDCG. Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medic...
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...
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