Oriel STAT A MATRIX's Process Validation training uses careful reviews of requirements from ISO 9001, ISO 13485 and QSR along with case studies and in-class activities, to teach the fundamentals and principles of process validation. Focus is on the planning, specifications, and requirements necessary to meet ISO and FDA requirements for process validation. FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."
Process validation training discussions and team workshops also cover interpretation of process validation as described by the Global Harmonization Task Force and as required by FDA's Medical Device Quality System Regulation, ISO 9001, ISO 13485.
To receive more in-depth Process Validation training, follow this course with Risk Management and Analysis for Medical Devices (course code FMF)
Bonus: Register for both courses and save $295 off of the combined total!