by Dr. Yashashwini Reddy | Apr 8, 2025
Feature Regulatory Affairs Quality Assurance Focus Legal compliance and market access Product quality and consistency Scope Entire product lifecycle, with an emphasis on regulatory requirements Entire product lifecycle, with an emphasis on quality standards Primary...
by Dr. Yashashwini Reddy | Apr 8, 2025
Clinical Research Associate (CRA): CRAs are tasked with overseeing clinical trials, ensuring adherence to protocols and regulations, and safeguarding the integrity of data. Clinical Research Coordinator (CRC): CRCs are responsible for the daily management of clinical...
by Dr. Yashashwini Reddy | Apr 5, 2025
The career paths in Pharmacovigilance or Drug Safety are both – knowledge and skill-based. One’s educational background in the field of medicine, be it – a physician, a dentist, a pharmacology student (and so on) – along with the skill sets acquired...
by Dr. Yashashwini Reddy | Nov 29, 2024
Advanced Questions and Answers on MS&T in Injectable Plants – Part 2 1. Troubleshooting and Continuous Improvement Question: What approach do you follow to troubleshoot a batch failure? Answer: Conduct a root cause analysis using tools like fishbone diagrams or 5...
by Dr. Yashashwini Reddy | Nov 27, 2024
1. What is Developmental Quality Assurance (DQA)? A: Developmental Quality Assurance ensures that quality is built into a product during its development stages. It involves reviewing documents, processes, and protocols to meet regulatory and quality standards...
