Cleanroom and Associate Controlled Environment

Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring.

Design of Experiment

Design of Experiments (DOE) is a systematic experimentation method. It is more efficient that the traditional experimentation methods such as the One-Factor-At-A-Time (OFAT) and Best Educated Guess. DOE employs statistic to model and optimize a process. It is widely used in process validation, parameter settings and developing a robust process

Effective Root Cause Analysis

The training provides the learner with a basic understanding of the principles and techniques of effective Root Cause Analysis and providing concepts needed to effectively perform investigation. The course is ideal for anyone who needs to understand the terminology and process of effective RCA.

Medical Device Manufacturing Process Validation

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.