21 CFR Part 211 Subpart G: Packaging and Labeling Control
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on packaging and labeling control for drug manufacturing, processing, packing, or holding. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on packaging and labeling control for drug manufacturing, processing, packing, or holding.
Curriculum for this course:
Introduction
| Overview | 1 min 01 secs |
| Who Should Take This Course? | 50 secs |
| Learning Objectives | 1 min 11 secs |
| Definitions | 1 min 50 secs |
Module 1: Materials Examination and Usage Criteria (Sect. 211.122)
| Written Procedures (a) | 1 min 05 sec |
| Approval or Rejection (b) | 1 min 10 secs |
| Maintenance and Storage (c)(d)(e) | 1 min 08 secs |
| Gang-Printed Labeling (f) | 1 min 10 secs |
| Special Control Procedures (g)(1-4) | 1 min 23 secs |
| Monitoring (h) | 1 min 02 secs |
Module 2: Labeling Issuance (Sect. 211.125)(a-f)
| Labeling Issuance (Sect. 211.125)(a-f) | 1 min 20 secs |
Module 3: Packaging and Labeling Operations (Sect. 211.130)(a-e)
| Packaging and Labeling Operations (Sect. 211.130)(a-e) | 1 min 01 secs |
Module 4: Tamper-Evident Packaging Requirements for Over-the-Counter (OTC) Human Drug Products (Sect. 211.132)
| General Requirements (a) | 1 min 10 secs |
| Requirements for Tamper-Evident Package (b)(1-2) | 1 min 01 secs |
| Labeling (c)(1)(i-iii)(2) | 1 min 25 secs |
| Request for Exemptions from Packaging and Labeling Requirements (d)(1-4) | 1 min 09 secs |
| OTC Drug Products Subject to Approved New Drug Applications (e) | 1 min 45 secs |
| Poison Prevention Packaging Act of 1970 (f) | 1 min 33 secs |
Module 5: Drug Product Inspection (Sect. 211.134) (a-c)
| Drug Product Inspection (Sect. 211.134) (a-c) | 1 min 23 secs |
Module 6: Expiration Dating (Sect. 211.137) (a-h)
| Expiration Dating (Sect. 211.137) (a-h) | 1 min 01 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-209 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Another great regulatory tool for any training department in Pharma.
Really well explained and I love how each section is aligned directly with the FDA regulations.
A timely reminder of how the regulations pertain to packaging and labeling.
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
cGMP – Cases from History and the Regulations
Contamination Prevention and Control in a GMP Environment
Corrective and Preventive Actions (CAPA)
How to be an Effective GMP Auditor – Part 1
How to be an Effective GMP Auditor – Part 2
How To Be An Effective GMP Auditor – Part 3
Talk to us
Find out how we can help you bring your life science training to the next level.