by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems 1. Objective To establish a validated cleaning procedure for Clean-in-Place (CIP) systems ensuring removal of product residues, cleaning agents, and microbial contaminants to acceptable levels. 2. Scope...
by Dr. Yashashwini Reddy | Aug 12, 2025
Understanding the US FDA Drug Approval Process The U.S. Food and Drug Administration (FDA) is responsible for ensuring that drugs marketed in the United States are safe, effective, and of high quality. The process is rigorous and involves multiple stages to verify...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧪Evaluating the Potential Risks and Benefits of the Research for Participants 🔍 1. What is Risk-Benefit Assessment in Clinical Research? Risk-Benefit Assessment is a critical ethical and scientific evaluation process in which researchers, sponsors, and ethics...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧾 Informed Consent in Clinical Research 🔍 1. What is Informed Consent? Informed Consent is a process by which a clinical trial participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of all...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧪 Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development 🔹 Introduction Good Clinical Practice (GCP) is an international ethical and scientific quality standard for...
