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Process Validation: Process Design

An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management.

Duration: 30 Mins

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SKU: BPU-1111-SPL07-EN Category: Biopharma Manufacturing Tag: BPU

Description

Description

Learning Objectives:

Describe the rationale for having a structured approach to Process Design
Explain what is meant by ‘Quality by Design’
Explain the concept of a ‘Quality Target Product Profile’
Define Critical Quality Attribute (CQA) and provide some examples
Explain why risk assessment is done as part of process design
Explain the concept of manufacturing ‘design space’ with reference to Design of Experiments and Critical Process Parameters
Define Process Control Strategy and Operational Control Strategy
Define Master Production Record and explain its relationship to Process Design studies

Module Features:

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