ROOT CAUSE ANALYSIS
INTRODUCTION: A crucial component of CAPA procedures in the pharmaceutical sector is root cause analysis (RCA). The goal of root cause analysis (RCA), a methodical technique used to research, is…
ISO 13485 vs. CFR Part 820
Introduction - Manufacturers of medical devices are subject to regulations worldwide to protect the consistency of their products. Manufacturers require a well-organized quality management system to do this. It is…
510 (k) VS PMA: Major differences
Introduction - The FDA typically requires you to complete a 510k submission or seek premarket approval for your medical device if you intend to manufacture or distribute it within the…
Types of 510(k) Overview
Introduction - The Food and Drug Administration (FDA) guarantees the efficacy and safety of medications, biologics, and medical devices. The FDA's medical device regulatory procedure is a significant obstacle to…
Introduction to 510 (k) Submission
Introduction - An FDA premarket submission is called a 510(k). Because it alludes to that particular portion of the Food, Drug, and Cosmetic Act, it is known as a 510(k).…
Clinical Evaluation Report (CER)
Introduction - A medical device's safety and assessment report is called a Clinical Evaluation Report (CER). It is based on clinical data from various device research and clinical investigations. A…
Analytical Method Validation in Pharmaceutical Quality Assurance
Introduction - An applied strategy to confirm that a procedure is appropriate to serve as a tool for quality control is called validation. Any analytical measurement's intent is to produce…
Product Development – API & Formulations
Overview - The terms used in drug formulations and active medicinal ingredients are widespread in the pharmaceutical business. It is a constant challenge for pharmaceutical corporations to develop new patent…
Computer System Validation in Pharma
In the fast-paced and highly regulated world of pharmaceuticals, computerized systems are integral to various processes, from research and development to manufacturing and distribution. Ensuring the efficacy, safety, and quality…
A Comprehensive Guide to Design Qualification in Pharma and Biotech Facilities
INTRODUCTION - Design Qualification includes all facets of facility and equipment design and acquisition. It is meant to have everything that could happen during the design, development, and checkout phases,…
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