BTEC 2222 Syllabus
Subject Code
BTEC
Course Number
2222
Course Title
Quality Assurance and Validation for Biomanufacturing
Prerequisites
Program admission
Corequisites
Terms Offered
Offered every semester
Credit Hours
(2-0-2)
Course Description
This course provides information on quality assurance and validation principles, together with their applications in the biotechnology, pharmaceutical, and medical device industries. Emphasis is placed on Food and Drug Administration (FDA) rationale, manufacturing processes, product quality, and documentation requirements.
Course Outcomes
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Fundamentals of validation
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Order
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Description
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1
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Explain the necessity of validation.
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2
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Describe the types of validation.
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3
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Understand validation planning.
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Audits
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Order
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Description
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1
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Describe the purpose of audits.
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2
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Differentiate between internal and external audits.
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Quality assurance activities
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Order
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Description
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1
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Review and release batch records.
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2
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Perform inspection and release of incoming materials.
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3
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Evaluate documentation for release of product.
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Documentation and data entry
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Order
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Description
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1
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Understand documentation requirements.
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2
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Organize electronic records.
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3
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Perform data entry.
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