Management Responsibilities & Qualifications Personnel in risk management need a combination of education, experience, skills, and certifications to effectively identify, assess, and manage risks. Here are the typical qualifications for risk management roles: 2. Professional…
Introduction to Risk Management Risk management in medical device manufacturing is a crucial process to identify, assess, mitigate, and monitor risks associated with the design, production, and use of medical devices. The goal is to…
Lean Preventive Maintenance (PM) and Corrective and Preventive Action (CAPA) Systems Implementing a Lean Preventive Maintenance (PM) System and a Corrective and Preventive Action (CAPA) System is essential for maintaining efficient operations and driving continuous…
Product & Process Documents Product DocumentsProduct documents describe the specific attributes, design, and characteristics of a product. They focus on defining what the product is, its components, design specifications, and the necessary information required for…
Features of Lean Design Documents Lean design documents are intentionally structured to ensure clarity, conciseness, and the elimination of waste. They provide precise yet complete information to support design, manufacturing, and validation processes. Let’s take…
Role of the Design History File Role of the Design History FileThe Design History File (DHF) is vital for documenting the design process, particularly in regulated industries such as medical devices, to ensure products meet…
ster Record (DMR): A DMR is a comprehensive set of documents that holds all the information needed to manufacture a product. It includes product specifications, manufacturing processes, quality control procedures, test methods, and packaging requirements. The…
Introduction Lean documentation stems from Lean manufacturing and Lean software development principles, emphasizing efficiency, value creation, and waste reduction. In Lean terminology, “waste” encompasses any activity that fails to add value to the final product…
December 4, 2020 – (SPARTA, NJ) – MEDVACON Life Sciences—a Quality, Compliance and Validation consulting company—is working with compounding pharmacies to help identify gaps in quality systems to ensure that they meet current FDA requirements to…
December 23, 2020 – (SPARTA, NJ) – When electronic records need to be validated, you can turn to Medvacon Life Sciences—a Quality, Compliance and Validation consulting company. And when it comes to Laboratory Information Management Systems…