Process Validation: Process Qualification and Control

• 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

Learner Benefits:

• Gain a comprehensive understanding of the critical stages of process validation—Process Qualification and Continued Process Verification-and their roles in achieving consistent product quality.

• Learn how to confirm that manufacturing processes are capable of reproducible, commercial-scale production through a detailed exploration of qualification and control strategies.

• Acquire knowledge of essential assessment tools and techniques, including statistical analysis and sampling plans, to verify process consistency and quality.

• Understand the role of change control in assessing process changes and how to implement requalification to maintain compliance and product integrity.

• Recognize the importance of cross-functional teamwork, involving production, quality, engineering, and validation teams, to maintain process control and enhance product quality.

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   Voice Over
    Knowledge Checks
    Assessments
   SCORM/AICC compatible
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