21 CFR Part 211 Subpart C – Building and Facilities
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Building and Facilities for drug manufacturing, processing, packing, or holding. 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 30 secs |
| Learning Objectives | 1 min 21 secs |
| Definitions | 1 min 10 secs |
Module 1: Design and Construction Features (Sect. 211.42)
| Space, Size and Location (a)(b) | 1 min 05 sec |
| Preventing Contamination and Mixups (c) (1 – 10)(i-vi) | 1 min 45 secs |
| Special Considerations for Penicillin (d) | 1 min 08 secs |
Module 2: Lighting (Sect. 211.44)
| Lighting (Sect. 211.44) | 1 min 12 secs |
Module 3: Ventilation, Air Filtration, Air Heating and Cooling (Sect. 211.46)
| General Requirements (a)(b) | 1 min 01 secs |
| Air Filtration Systems (c) | 1 min 13 secs |
| Special Considerations for Penicillin (d) | 1 min 33 secs |
Module 4: Plumbing (Sect. 211.48)
| Potable Water (a) | 1 min 10 secs |
| Drains (b) | 1 min 01 secs |
Module 5: Sewage and Refuse (Sect. 211.50)
| Sewage and Refuse (Sect. 211.50) | 1 min 23 secs |
Module 6: Washing and Toilet Facilities (Sect. 211.52)
| Washing and Toilet Facilities (Sect. 211.52) | 1 min 01 secs |
Module 7: Sanitation (Sect. 211.56)
| General Requirements (a) | 1 min 11 secs |
| Sanitation Procedures (b)(c)(d) | 1 min 33 secs |
Module 8: Maintenance (Sect. 211.58)
| Maintenance (Sect. 211.58) | 1 min 25 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-205 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
We have incorporated this training into our onboarding process for all manufacturing engineers.
Anyone who works in a GMP manufacturing environment needs to do this course to understand how the regulations apply.
Very easy to understand and a perfect way to appreciate the regulatory requirements.
Related courses:
21 CFR Part 211 Subpart F: Production and Process Controls
21 CFR Part 211 Subpart J – Records and Reports
Good Manufacturing Practices – QMS, Premises and Personnel
cGMP – Cases from History and the Regulations
cGMP – Equipment, Validation, Complaints and Self Inspection
Good Manufacturing Practices (cGMP)
Combination Products (Drugs, Devices and Biologics) – Part 1
Combination Products (Drugs, Devices and Biologics) – Part 2
Combination Products (Drugs, Devices and Biologics) – Part 3
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