21 CFR Part 211 Subpart D – Equipment
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations for equipment used for drug manufacturing and related processes. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. A link to these regulations on the FDA’s website is available in the Resources tab of this course. 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 |
Equipment Design, Size, and Location (Sect. 211.63)
| Equipment Design, Size, and Location | 1 min 15 secs |
Equipment Construction (Sect. 211.65)
| Materials Used for Construction | 1 min 20 secs |
| Substances Required for Operation | 1 mins 29 secs |
Equipment Cleaning and Maintenance (Sect. 211.67)
| Cleaning and Sterilization | 1 min 01 secs |
| Written Procedures | 1 min 13 secs |
| Recordkeeping | 1 min 20 secs |
Automatic, Mechanical, and Electronic Equipment (Sect. 211.68)
| Calibration and Inspection | 1 min 15 secs |
| Computer System Controls and Validation | 1 min 01 secs |
| Checking Performance of Automated Equipment | 1 min 25 secs |
Filters (Sect. 211.72)
| Filters | 1 min 23 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-212 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Another great training program to add to our GMP training portfolio.
This is a must do course for anyone who works in a GMP environment and wants to understand the importance of working with equipment properly.
This course should be taken by everyone working in a GMP manufacturing environment before SOP training.
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
21 CFR Part 211 Subpart H – Holding and Distribution
21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures
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