Process Validation In The Medical Device Industry

Validation of manufacturing processes in the cGMP environment is recognized by the medical manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. This course will provide guidance and instruction governing the Process Validation process and proper implementation within a medical device manufacturer. This will include defining process validation, when it is required, the three phases of process validation, who conducts the validation process, proper protocols and procedures, writing final reports. This instruction will not include product verification or validation, except in terminology and their relationship to the process validation.

This 2-day accredited training will prepare individual to describe the role of Process Validation as product begins to move from Research and Development to Production. Individuals will be instructed in establishing the various roles of personnel from various departments, the development of the protocol used in Process Validation, understanding the process of IQ/OQ/PQ, performing the protocol requirements for the Process Validation, analyzing results, and properly closing out the Process Validation step to further the product for design transfer.