21 CFR Part 211 Subpart J – Records and Reports
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Records and Reports 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 31 secs |
| Learning Objectives | 1 min 11 secs |
| Definitions | 1 min 25 secs |
Module 1: General Requirements (Sect. 211.180)
| Required Length of Time to Retain Records (a)(b) | 1 min 05 sec |
| Availability of Records and Reports (c)(d) | 50 secs |
| Written Records and Procedures for Annual Evaluation (e)(1)(2) | 1 min 08 secs |
| Notification of Responsible Parties (f) | 1 min 17 secs |
Module 2: Equipment Cleaning and Use Log (Sect. 211.182)
| Equipment Cleaning and Use Log (Sect. 211.182) | 1 min 12 secs |
Module 3: Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)
| Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)(a)(b)(c)(d)(e) | 1 min 01 secs |
Module 4: Master Production and Control Records (Sect. 211.186)(a)
| Master Production and Control Records Requirements (b)(1-9) | 1 min 10 secs |
Module 5: Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13)
| Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13) | 1 min 23 secs |
Module 6: Production Record Review (Sect. 211.192)
| Production Record Review (Sect. 211.192) | 1 min 01 secs |
Module 7: Laboratory Records (Sect. 211.194)(a)(1-8)
| Laboratory Records: Additional Requirements (b)(c)(d)(e) | 1 min 11 secs |
Module 8: Distribution Records (Sect. 211.196)
| Distribution Records (Sect. 211.196) | 1 min 25 secs |
Module 9: Complaint Files (Sect. 211.198)
| Written Procedures (a) | 1 min 09 secs |
| Complaint File Creation and Maintenance (b) | 1 min 19 secs |
| Written Record (1)(2)(3) | 1 min 21 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-210 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
An excellent course explaining in detail and aligned with the regulations the importance of records and reports.
Particularly liked the batch production and control records section.
A must do course for anyone working in a laboratory testing GMP product.
Related courses:
21 CFR Part 211 Subpart F: Production and Process Controls
Good Manufacturing Practices – QMS, Premises and Personnel
cGMP – Cases from History and the Regulations
cGMP – Equipment, Validation, Complaints and Self Inspection
How to be an Effective GMP Auditor – Part 1
Corrective and Preventive Actions (CAPA)
Contamination Prevention and Control in a GMP Environment
Good Manufacturing Practices (cGMP)
Good Manufacturing Practices – Good Practices and Quality Control
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