CEU Credits: 0.1
Course Code: ELM-263
Duration: 15 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: v1.1
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!
v1.2 | Minor update on 05/27/2026. Onscreen text and formatting improvements implemented. Course content has not been changed.
v1.1 | Minor update on 05/22/2025. 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 09/16/2024