21 CFR Part 211 Subpart B: Organization and Personnel
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on organization and personnel. 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 |
Responsibilities of the Quality Control Unit (Sect. 211.22)
| Drug Product Approval, Rejection, and Records Review | 1 min 05 sec |
| Adequacy of Laboratory Facilities | 1 min 10 secs |
| Approval and Rejection of Procedures and Specifications | 1 min 10 secs |
Personnel Qualifications (Sect. 211.25)
| Job and cGMP Training | 1 min 12 secs |
| Qualifications for Supervisory Roles | 1 mins 29 secs |
| Number of Qualified Personnel | 1 min 02 secs |
Personnel Responsibilities (Sect. 211.28)
| Clothing and PPE | 1 min 01 secs |
| Sanitation and Authorized Access | 1 min 13 secs |
| Illness and Injury | 1 min 20 secs |
Consultants (Sect. 211.34)
| Consultants (Sect. 211.34) | 1 min 10 secs |
Conclusion
Final Assessment
Certification
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-211 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This course links the responsibilities to the regulations, something all personnel in a GMP environment need to understand.
So much better than rolling out the same presentation each year!
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
21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products
Course code: ELM-213
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