Good Manufacturing Practices

In-Process Sampling and Testing

This introduction to sampling and testing in life science manufacturing will explore the key principles, methodologies, and considerations that underlie this important aspect of biopharmaceutical production.

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CEU Credits: 0.1
Course Code: ELM-736
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 06/03/2024

Curriculum for this course

Course Introduction
Why Sample and Test?
Sampling Plan
Routine vs. Non-Routine
Acceptance Criteria
Knowledge Check
Buffer or Media Samples
Product or Process Samples
Rinse Water Samples
Assays and Testing
Sampling Apparatus
Aseptic Practices During Sampling
Guidelines for Sample Collection
What Happens If You Don't Sample?
Does Anyone Need to be Present for Sampling?
Summary
Test Your Knowledge
v1.1 Minor update on 01/30/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course released on 07/19/2024
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Author

Daniel Cole

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