Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. Why should you attend:Medical device manufacturers have always been under […]
Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.
Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone. we never expected to actually to connect with other people in the blogging community. we are so incredibly […]
The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies. The Quality […]
Software as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these. Where SaaS differs as a method […]
Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among […]
Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software. SaaS is a fundamentally different method […]
Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as: Analytical methods validation Procedures and acceptance criteria in calibration limits Process and Quality Control Process and quality controls ICH Q8 and Q9. The ICH tripartite-harmonized ICH Guideline on Text, which […]
The Agile methodology is an important tool for software project management.
A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as […]