CFRs Part 210 and 211 : cGMPs for Finished Pharmaceuticals

Dive deep into the nuances of pharmaceutical manufacturing regulations with this certified eLearning course, focused on the FDA’s CFRs 210 & 211. Understand the distinctions between these regulations as they detail various aspects of the pharmaceutical manufacturing process.

Course Highlights:

• Complete breakdown from the general provisions to records and reports.
• Insights into the control of components, packaging, labeling, and more.
• Practical understandings of the regulations for both Operations Leaders and Quality Managers.

Guided by Dr. Ciaran McEnister, a seasoned Pharmaceutical Executive boasting over 25 years in regulatory compliance, learners gain a comprehensive perspective. Dr. McEnister’s extensive tenure at top-tier firms ensures this course is steeped in real-world expertise.

This course is suitable for anyone working in manufacturing/operations or Quality Control for pharmaceutical products marketed or distributed in the United States (US).

On successful completion, attendees earn a downloadable and traceable Certificate of Completion that you can share on linkedin or your personnal HR records. Embark on a self-paced regulatory journey now and enhance your expertise in the US FDA requirements for finished pharmaceuticals.

Curriculum:

Overview of 21 CFR Part 210 & 211

Lesson 1: Subpart A – General Provisions

Lesson 2: Subpart B – Organization and Personnel

Lesson 3: Subpart C – Buildings and Facilities

Lesson 4: Subpart D – Equipment

Lesson 5: Subpart E – Control of Components and Drug Product Containers and Closures

Lesson 6: Subpart F – Production and Process Controls

Lesson 7: Subpart G – Packaging and Labeling Control

Lesson 8: Subpart H – Holding and Distribution

Lesson 9: Subpart I – Laboratory Controls

Lesson 10: Subpart J – Records and Reports

Lesson 11: Subpart K – Returned and Salvaged Drug Products

Conclusion

Evaluation

Certification