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Process Validation: Process Qualification and Control

An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical process is capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.

Duration: 30 Mins

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SKU: BPU-1112-SPL03-EN Category: Biopharma Manufacturing Tag: BPU

Description

Description

Learning Objectives:

Explain the purpose of process qualification
State the pre-requisites that must be in place before process qualification can proceed
Summarize the activities that occur in process qualification
Explain the purpose of continued process verification
Describe some of the assessment tools used in continued process verification
Explain the role of change control in assessing changes to validated processes
Provide an example of where requalification would be necessary

Module Features:

Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen