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.

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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!
Todd Elfstrom profile picture

Author

Todd Elfstrom

Pharmaceutical Quality Specialist, Vertex Pharmaceuticals

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