21 CFR Part 211 Subpart F: Production and Process Controls
Description:
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on production and process controls 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 10 secs |
Module 1: Written Procedures and Deviations (Sect. 211.100)(a)(b)
| Written Procedures and Deviations (Sect. 211.100)(a)(b) | 1 min 05 secs |
Module 2: Charge-In of Components (Sect. 211.101)
| Preserving the Active Ingredient (a) | 1 min 20 secs |
| Removal of Components from the Original Container (b)(1-4) | 1 mins 29 secs |
| Supervision and Secondary Examination (c)(1-3) | 1 min 55 secs |
| Verifying the Batch (d) | 1 min 25 secs |
Module 3: Calculation of Yield (Sect. 211.103)
| Key Terms | 1 min 01 secs |
| Determining Actual Yields and Percentages | 1 min 13 secs |
Module 4: Equipment Identification (Sect. 211.105)
| Equipment Identification (Sect. 211.105)(a)(b) | 1 min 15 secs |
Module 5: Sampling and Testing of In-Process Materials and Drug Products (Sect. 211.110)
| Key Terms | 1 min 23 secs |
| Written Procedures (a)(1-6) | 1 min 50 secs |
| Specifications (b) | 1 min 06 secs |
| In-Process Materials (c)(d) | 1 min 35 secs |
Module 6: Time Limitations on Production (Sect. 211.111)
| Time Limitations on Production (Sect. 211.111) | 1 min 01 secs |
Module 7: Control of Microbiological Contamination (Sect. 211.113)(a)(b)
| Control of Microbiological Contamination (Sect. 211.113)(a)(b) | 1 min 11 secs |
Module 8: Reprocessing (Sect. 211.115)(a)(b)
| Reprocessing (Sect. 211.115)(a)(b) | 1 min 25 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-208 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
The direct correlation to the Part 211 regulations is amazing, now we can really focus on who is trained on what aspects of GMP.
I can rest assured that our associates are trained on the correct regulations.
Finally, a course that explains the regulations behind production and process controls.
Related courses:
Good Manufacturing Practices – QMS, Premises and Personnel
cGMP – Cases from History and the Regulations
cGMP – Equipment, Validation, Complaints and Self Inspection
Contamination Prevention and Control in a GMP Environment
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
21 CFR Part 820 Subpart G – Production and Process Controls
Corrective and Preventive Actions (CAPA)
How to Manage Deviations in a GMP Environment – Part 1
Good Manufacturing Practices (cGMP)
Talk to us
Find out how we can help you bring your life science training to the next level.