21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on returned and salvaged drug products. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211.
Curriculum for this course:
Introduction
| Overview | 1 min 01 secs |
| Who Should Take This Course? | 1 min 31 secs |
| Learning Objectives | 1 min 25 secs |
| Definitions | 1 min 15 secs |
Returned and Salvaged Drug Products (Sect. 211.204)
| Returned and Salvaged Drug Products | 1 min 05 sec |
Returned Drug Products
| Identification and Holding of Returned Drug Products | 1 min 20 secs |
| Reprocessing of Returned Drug Products | 1 mins 29 secs |
| Recordkeeping and Investigation of Returned Drug Products | 1 min 21 secs |
Drug Product Salvaging (Sect. 211.208)
| Drug Salvaging Basics | 1 min 01 secs |
| Handling Questionable Conditions of Salvaging | 1 min 13 secs |
| FDA Guidance on Drug Salvaging | 1 min 05 secs |
| Improper Storage Conditions: Natural Disasters | 1 min 06 secs |
| Improper Storage Conditions: Toxic Fumes and Radiation | 1 min 19 secs |
| Considerations for Assessing Radioactive Material Contamination | 1 min 27 secs |
Conclusion
Final Assessment
Certification
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-213 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
A superb way to train your employees in a topic that is often overlooked but needs careful consideration.
Another great course in the 21 CFR Part 211 series. A must do program for anyone working in the GMP world.
Related courses:
21 CFR Part 211 Subpart F: Production and Process Controls
Course code: ELM-208
21 CFR Part 211 Subpart J – Records and Reports
Course code: ELM-210
21 CFR Part 211 Subpart C – Building and Facilities
Course code: ELM-205
21 CFR Part 211 Subpart G: Packaging and Labeling Control
Course code: ELM-209
21 CFR Part 211 Subpart H – Holding and Distribution
Course code: ELM-207
21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures
Course code: ELM-206
21 CFR Part 211 Subpart D – Equipment
Course code: ELM-212
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