Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the eff ...
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test ...
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Th ...
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...
Supplier/Vendor Managed Inventory is a program that optimizes supply chain performance. The supplier and the customer learn to operate in a mutually beneficial manner that provides financial gains as well. It is a process for resupplying inventory in an expe ...
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...
This program presents insights into the responsibilities of both Buyers and Planners. Not only are technical aspects addressed, but the contents also speak about the interfacing challenges that they will face in a Buyer/Planner (B/P) system. Traditional rol ...
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
Data integrity is the assurance that data records are accurate, complete, intact, and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hy ...