CFRs Part 210 and 211 : cGMPs for Finished Pharmaceuticals

cgmp cfr 210

Duration :



Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



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 ourย 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 FDAโ€™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.




Overview of 21 CFR Part 210 & 211

Lesson 1: Subpart A โ€“ General Provisions

Lesson 2: Subpart B โ€“ Organization and Personnel

Lesson 3: Subpart C โ€“ Buildings and Facilities

Lesson 4: Subpart D โ€“ Equipment

Lesson 5: Subpart E โ€“ Control of Components and Drug Product Containers and Closures

Lesson 6: Subpart F โ€“ Production and Process Controls

Lesson 7: Subpart G โ€“ Packaging and Labeling Control

Lesson 8: Subpart H โ€“ Holding and Distribution

Lesson 9: Subpart I โ€“ Laboratory Controls

Lesson 10: Subpart J โ€“ Records and Reports

Lesson 11: Subpart K โ€“ Returned and Salvaged Drug Products





Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in medical device development. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.


USD: United States (US) dollar ($) ^


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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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