Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart F: Production and Process Controls

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.

CEU Credits: 0.1
Course Code: ELM-208
Duration: 45 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Who Should Take This Course?
Learning Objectives
Definitions
Written Procedures and Deviations (Sect. 211.100)(a)(b)
Preserving the Active Ingredient (a)
Removal of Components from the Original Container (b)(1-4)
Supervision and Secondary Examination (c)(1-3)
Verifying the Batch (d)
Key Terms
Determining Actual Yields and Percentages
Equipment Identification (Sect. 211.105)(a)(b)
Key Terms
Written Procedures (a)(1-6)
Specifications (b)
In-Process Materials (c)(d)
Time Limitations on Production (Sect. 211.111)
Control of Microbiological Contamination (Sect. 211.113)(a)(b)
Reprocessing (Sect. 211.115)(a)(b)

Conclusion

Final Assessment

Certification