Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
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.
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.
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