21 CFR Part 211 Subpart H – Holding and Distribution
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on holding and distribution of drug products. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.
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 |
Drug Warehousing and Distribution
| Warehousing Procedures (Sect. 211.142)(a)(b) | 1 min 05 sec |
| Distribution Procedures (Sect. 211.150)(a)(b) | 1 min 45 secs |
| What is a Product Recall? | 1 min 10 secs |
| Recalls: Over-the-Counter vs. Prescription Drugs | 1 min 17 secs |
| Voluntary vs. Involuntary Recalls | 1 min 48 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-207 -
Duration: 30 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Finally, an awesome course that helps our warehouse staff understand how they fit into the GMP chain.
When you correlate the importance of warehousing to the actual regulations it makes a huge difference.
Related courses:
21 CFR Part 211 Subpart F: Production and Process Controls
21 CFR Part 211 Subpart J – Records and Reports
21 CFR Part 211 Subpart C – Building and Facilities
21 CFR Part 211 Subpart G: Packaging and Labeling Control
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