DUBLIN--(BUSINESS WIRE)--The "Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing" conference has been added to Research and Markets' offering.
The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry.
The flow of topics over the 2 days is as follows:
- ISO standards and FDA/MDD regulations regarding the use of statistics.
- Basic vocabulary and concepts.
- Statistical Process Control
- Statistical methods for Design Verification
- Statistical methods for Product/Process Qualification
- Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
- How to craft "statistically valid conclusion statements" (e.g., for reports)
Summary, from a risk management perspective
Areas Covered in the Session:
- FDA, ISO 9001/13485, and MDD requirements related to statistical methods
- How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
- Design Control processes (verification, validation, risk management, design input)
- QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
Manufacturing processes (process validation, equipment qualification)
For more information about this conference visit https://www.researchandmarkets.com/research/rg2xf6/applied