21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Control of Components and Drug Product Containers and Closures for drug manufacturing, processing, packing, or holding. 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? | 58 secs |
| Learning Objectives | 1 min 21 secs |
| Definitions | 1 min 10 secs |
Module 1: General Requirements (Sect. 211.80) (a)(b)(c)(d)
| General Requirements (Sect. 211.80) (a)(b)(c)(d) | 1 min 15 secs |
Module 2: Receipt and Storage of Untested Components, Drug Product Containers, and Closures (Sect. 211.82) (a)(b)
| Receipt and Storage of Untested Components, Drug Product Containers, and Closures (Sect. 211.82) (a)(b) | 1 min 12 secs |
Module 3: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures (Sect. 211.84)
| General Instructions (a)(b) | 1 min 01 secs |
| Sample Collection Procedure (c)(1-6) | 1 min 13 secs |
| Sample Testing Procedure (d)(1-6) | 1 min 33 secs |
| Approval or Rejection (e) | 1 min 06 secs |
Module 4: Use of Approved Components, Drug Product Containers, and Closures (Sect. 211.86)
| Use of Approved Components, Drug Product Containers, and Closures (Sect. 211.86) | 1 min 10 secs |
Module 5: Retesting of Approved Components, Drug Product Containers, and Closures (Sect. 211.87)
| Retesting of Approved Components, Drug Product Containers, and Closures (Sect. 211.87) | 1 min 23 secs |
Module 6: Rejected Components, Drug Product Containers, and Closures (Sect. 211.89)
| Rejected Components, Drug Product Containers, and Closures (Sect. 211.89) | 1 min 01 secs |
Module 7: Overview: Drug Product Containers and Closures (Sect. 211.94)
| Drug Product Containers and Closures (a)(b)(c)(d) | 1 min 11 secs |
| Medical Gas Containers and Closures (e) | 1 min 33 secs |
| Gas-Specific Use Outlet Connections (1) | 1 min 09 secs |
| Label and Coloring Requirements (2) | 1 min 15 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-206 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
A much-overlooked topic that forms an integral part of the over GMP process.
The correlation to the regulations on the FDA website really struck home how important this side of the process is.
A must do course for anyone working in GMP manufacturing.
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
Private: An Introduction to Good Manufacturing Practices (cGMP)
Good Manufacturing Practices – QMS, Premises and Personnel
Types of Contamination in a GMP Environment
Sources of Contamination in a GMP Environment
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