Good Manufacturing Practices (cGMP) - Intermediate

Batch/Product Release

Similar to designing and firing off a rocket into space, launching a pharmaceutical product is a complex and dynamic journey. This course examines the intricate steps involved in getting your medication to market safely and effectively.

CEU Credits: 0.1
Course Code: ELM-263
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 07/08/2024

Curriculum for this course

Three, Two, One…
Premanufacturing Steps
Regulations & GMP Guidelines
In-house vs CMOs
Quality Assurance
Batches
Batch Release Record Review: Who Does It?
Batch Release Record Review: What Gets Reviewed?
Drug Product Quality Testing
Aberrant Results
Testing Types
Other Investigations
Special Situations That May Impact Release
Releasing the Product
The Final Frontier
Test Your Knowledge!
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Author

Todd Elfstrom

Pharmaceutical Quality Specialist, Vertex Pharmaceuticals

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