The use of Applied Statistics for FDA Process Validation

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA […]

Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls. Statistical sampling plans for medical devices needs to be seen in this […]

Statistics for Medical Professionals

Medical statistics, also called biostatistics, is an important area for medical professionals. Statistics and the medical professionals may not seem very easily associable with each other at first glance, but a deeper look suggests the connection between statistics and the medical profession. Statistics is a set of data and tables. These figures are meant to […]

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions: o  Setting validation criteria and specifications o  Performing Measurement Systems Analysis (MSA) o  Conducting stability analysis o  Using Design of Experiment (DOE) for process […]

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made: Managing risks Validation of processes Establishing product/process specifications to QC to such specifications Monitoring compliance to such specifications Lack of proper and thorough grasp of and correct implementation of […]

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made: Managing risks Validation of processes Establishing product/process specifications to QC to such specifications Monitoring compliance to such specifications Lack of proper and thorough grasp of and correct implementation of […]