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About

The 21 CFR Part 210 & 211 Course is designed to provide a comprehensive understanding of current Good Manufacturing Practice (cGMP) regulations governing the manufacture, processing, packing, and holding of pharmaceutical products in the United States. It emphasizes regulatory compliance requirements established by the U.S. Food and Drug Administration (FDA) to ensure drug safety, quality, identity, strength, and purity.
This course covers key areas including quality management systems, personnel qualifications, facilities and equipment controls, production and process controls, laboratory controls, documentation practices, packaging and labeling operations, warehousing and distribution, complaint handling, returned products, and record retention requirements. It also highlights Quality Control Unit (QCU) responsibilities, data integrity principles, inspection readiness, and practical application of FDA cGMP regulations in pharmaceutical manufacturing environments. Upon completion, learners receive a certification demonstrating competency in 21 CFR Part 210 & 211 compliance and pharmaceutical quality systems.

Who Should Enrol?

  • Quality Assurance (QA) Professionals
  • Quality Control (QC) Analysts and Supervisors
  • Manufacturing and Production Personnel
  • Validation and Qualification Specialists
  • Regulatory Affairs Professionals
  • Warehouse, Packaging, and Distribution Personnel
  • Pharmaceutical, Biotechnology, and Contract Manufacturing Professionals
  • Life Science, Pharmacy, Chemistry, and Biotechnology Graduates
  • Professionals preparing for FDA inspections and GMP audits

What you will learn

Understand the fundamentals of 21 CFR Parts 210 & 211, including FDA current Good Manufacturing Practice (cGMP) requirements, quality systems, and the regulatory framework governing finished pharmaceutical manufacturing.

Gain knowledge of personnel, facilities, equipment, laboratory controls, production and process controls, documentation practices, and Quality Control Unit (QCU) responsibilities required to ensure product quality and compliance.

Learn end-to-end GMP operations including materials management, packaging and labeling controls, warehousing and distribution, stability programs, batch record management, complaint handling, and product recalls.

Develop expertise in data integrity, deviation investigations, CAPA, inspection readiness, risk management, and practical application of FDA cGMP requirements to maintain compliance and support successful regulatory inspections.

Course Syllabus

  1. 21 CFR Part 210 vs. Part 211
  2. Why this matters — US market access depends on it
  3. What Part 210 covers
  4. Roadmap — The eleven subparts, A to K
  5. How you'll learn
  6. Who should take this course
  7. Course highlights
  8. How FDA inspects — the QSIT framework
  9. How you'll learn
  10. Credential — Certificate of completion

  1. Subpart A — scope of the whole regulation
  2. Scope — what Part 211 covers
  3. Key definitions (with Part 210)
  4. What FDA means by minimum cGMP
  5. Part 210 — the definitions layer
  6. Non-compliance = adulterated product
  7. Practical implications for operations + quality
  8. cGMP requirements not being met
  9. How Subpart A links to other FDA regs
  10. Subpart A self-audit

  1. Four sections in Subpart B
  2. Section 211.22 — Quality Control Unit independence + release authority
  3. Section 211.25 — qualifications, training, experience
  4. Section 211.28 — hygiene, clothing, health, access control
  5. Section 211.34 — consultants under the quality system
  6. Why QCU independence is non-negotiable
  7. Training — initial + continuing
  8. Audit risk flag - Training + personnel findings
  9. Who decides what — Subpart B roles
  10. Subpart B self-audit

  1. Sections in Subpart C
  2. Section 211.42 — design + construction to prevent mix-ups
  3. Section 211.46 — HVAC expectations
  4. Section 211.48 — plumbing + water
  5. Sections 211.50+211.56 — sewage + sanitation
  6. Section 211.58 — maintenance
  7. Practical discipline for operations
  8. Audit Risk Flag — Facility findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart D
  2. Section 211.63 — design, size, location
  3. Section 211.65 — contact surfaces
  4. Section 211.67 — cleaning + maintenance
  5. Section 211.68 — automatic + electronic
  6. Section 211.72 — filters
  7. Practical discipline for operations
  8. Audit Risk Flag — Equipment findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart E
  2. Section 211.82 — receipt + storage
  3. Section 211.84 — identity testing + approval/rejection
  4. Section 211.86 — FEFO, retesting, rejected components
  5. Section 211.87 — Retesting
  6. Section 211.89 + 211.94 — Rejected + containers
  7. Practical discipline for operations
  8. Audit Risk Flag — Component findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart F
  2. Section 211.100 — written procedures + deviations
  3. Section 211.101 — charge-in + yield reconciliation
  4. Section 211.110 — In-process sampling + testing
  5. Sections 211.103 + 211.105 — Yield + equipment ID
  6. Sections 211.113 + 211.115 — Contamination + rework
  7. Practical discipline for operations
  8. Audit Risk Flag — Production + process findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart G
  2. Section 211.122 — materials + procedures
  3. Section 211.125 — issuance of labeling
  4. Section 211.130 — Packaging + labeling operations
  5. Section 211.132 — tamper-evident packaging (OTC)
  6. Sections 211.134+211.137 — inspection + expiration dating
  7. Practical discipline for operations
  8. Audit Risk Flag — Packaging + labelling findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart H
  2. Section 211.142 — warehousing
  3. Section 211.150 — distribution + FEFO
  4. Cold chain
  5. Mock recalls
  6. Reverse logistics
  7. Practical discipline for operations
  8. Audit Risk Flag — Distribution findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart I
  2. Section 211.160 — general lab controls
  3. Section 211.165 — testing + release
  4. Section 211.166 — stability
  5. Sections 211.170 + 211.173 — reserve samples + animals
  6. Section 211.176 — penicillin
  7. Practical discipline for operations
  8. Audit Risk Flag — Laboratory findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart J
  2. Section 211.180 — general retention
  3. Section 211.186 — master production records
  4. Section 211.188 — batch records
  5. Section 211.196 — Production record review
  6. Sections 211.194 + .196 + .198 — Lab + distribution + complaints
  7. Practical discipline for operations
  8. Audit Risk Flag — Records + reports findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Sections in Subpart K
  2. Section 211.204 — returned drug products
  3. Section 211.208 — salvaging
  4. When returns happen
  5. Handling discipline
  6. Records + documentation
  7. Practical discipline for operations
  8. Audit Risk Flag — Returned + salvaged findings
  9. Operations + quality interface
  10. Subpart self-audit

  1. Ten Habits of a Compliant Manufacturer
  2. After certification — apply what you learned
  3. Course Complete

Course Benefits

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any changes to 21 CFR Parts 210 and 211, FDA cGMP guidance and current FDA inspection and Form 483 trends, as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by pharmaceutical GMP and regulatory compliance practitioners to ensure that learners can apply 21 CFR 210/211 with confidence on the floor, in the lab and in front of an FDA investigator.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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