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Specialist · Good practice (GxP)

US FDA Current Good Manufacturing Practice (cGMP) Implementation for Pharmaceuticals (21 CFR Parts 210 and 211)

Build a site that is ready for an FDA inspection every day.

A specialist course on implementing 21 CFR Parts 210 and 211 with FDA guidance and ICH Q7, Q9 and Q10: the quality system and quality unit, facilities, equipment and cleaning validation, materials and suppliers, production and process validation, packaging, the laboratory and OOS, data integrity, CAPA, change control and FDA inspections.

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Standard and editionUS FDA cGMP: 21 CFR Parts 210 and 211

Last updated4 October 2026

Preview this course

Experience the learning
before you enrol.

Watch a sample from US FDA Current Good Manufacturing Practice (cGMP) Implementation for Pharmaceuticals (21 CFR Parts 210 and 211) before you enrol.

US FDA Current Good Manufacturing Practice (cGMP) Implementation for Pharmaceuticals (21 CFR Parts 210 and 211)Sample

Learning outcomes

Knowledge you can put to work.

Connect the subject to the responsibilities and decisions people encounter in their roles.

  • Explain who must follow 21 CFR Parts 210 and 211 and how FDA guidance and ICH Q7, Q9 and Q10 support them
  • Set up the quality unit, quality system and quality risk management
  • Plan qualification, cleaning validation and process validation
  • Run laboratory controls, OOS investigations and data integrity controls
  • Prepare a site for an FDA inspection and a credible 483 response

Part of: Pharmaceutical GMP and GDP Training

Inside the course

A clear path through the essentials.

40 modules, 40 practice checkpoints and a final exam. Video runtimes are approximate; allow additional time for the practice questions and the final exam.

Part 1Module 1Approx. 10 min
  1. Why US cGMP pays10 min
  2. Practice: Why US cGMP pays3 questions
Part 2Module 2Approx. 8 min
  1. The law and who must follow it8 min
  2. Practice: The law and who must follow it3 questions
Part 3Module 3Approx. 8 min
  1. A map of Part 211 and its key terms8 min
  2. Practice: A map of Part 211 and its key terms3 questions
Part 4Module 4Approx. 8 min
  1. The pharmaceutical quality system8 min
  2. Practice: The pharmaceutical quality system3 questions
Part 5Module 5Approx. 8 min
  1. Quality risk management8 min
  2. Practice: Quality risk management3 questions
Part 6Module 6Approx. 8 min
  1. The quality unit in practice8 min
  2. Practice: The quality unit in practice3 questions
Part 7Module 7Approx. 7 min
  1. People: qualifications, training and hygiene7 min
  2. Practice: People: qualifications, training and hygiene3 questions
Part 8Module 8Approx. 8 min
  1. Writing SOPs that work8 min
  2. Practice: Writing SOPs that work3 questions
Part 9Module 9Approx. 8 min
  1. Buildings and facilities8 min
  2. Practice: Buildings and facilities3 questions
Part 10Module 10Approx. 7 min
  1. Equipment: design, cleaning, maintenance, logs7 min
  2. Practice: Equipment: design, cleaning, maintenance, logs3 questions
Part 11Module 11Approx. 8 min
  1. Equipment qualification: IQ, OQ, PQ8 min
  2. Practice: Equipment qualification: IQ, OQ, PQ3 questions
Part 12Module 12Approx. 8 min
  1. Cleaning validation8 min
  2. Practice: Cleaning validation3 questions
Part 13Module 13Approx. 8 min
  1. Components, containers and closures8 min
  2. Practice: Components, containers and closures3 questions
Part 14Module 14Approx. 8 min
  1. Supplier qualification8 min
  2. Practice: Supplier qualification3 questions
Part 15Module 15Approx. 7 min
  1. Production controls: charge-in, yield, time limits7 min
  2. Practice: Production controls: charge-in, yield, time limits3 questions
Part 16Module 16Approx. 7 min
  1. In-process controls, microbes and reprocessing7 min
  2. Practice: In-process controls, microbes and reprocessing3 questions
Part 17Module 17Approx. 8 min
  1. The master production record8 min
  2. Practice: The master production record3 questions
Part 18Module 18Approx. 7 min
  1. The batch record and its review7 min
  2. Practice: The batch record and its review3 questions
Part 19Module 19Approx. 8 min
  1. Process validation: design and qualification8 min
  2. Practice: Process validation: design and qualification3 questions
Part 20Module 20Approx. 7 min
  1. Continued process verification7 min
  2. Practice: Continued process verification3 questions
Part 21Module 21Approx. 9 min
  1. Packaging and labelling control9 min
  2. Practice: Packaging and labelling control3 questions
Part 22Module 22Approx. 8 min
  1. Warehousing and distribution records8 min
  2. Practice: Warehousing and distribution records3 questions
Part 23Module 23Approx. 8 min
  1. Laboratory controls8 min
  2. Practice: Laboratory controls3 questions
Part 24Module 24Approx. 8 min
  1. Stability and expiry dating8 min
  2. Practice: Stability and expiry dating3 questions
Part 25Module 25Approx. 8 min
  1. Reserve samples and special testing8 min
  2. Practice: Reserve samples and special testing3 questions
Part 26Module 26Approx. 8 min
  1. OOS investigation, part 1: the laboratory phase8 min
  2. Practice: OOS investigation, part 1: the laboratory phase3 questions
Part 27Module 27Approx. 8 min
  1. OOS investigation, part 2: full investigation and decision8 min
  2. Practice: OOS investigation, part 2: full investigation and decision3 questions
Part 28Module 28Approx. 7 min
  1. Data integrity and ALCOA+7 min
  2. Practice: Data integrity and ALCOA+3 questions
Part 29Module 29Approx. 8 min
  1. Part 11 and computerised systems8 min
  2. Practice: Part 11 and computerised systems3 questions
Part 30Module 30Approx. 8 min
  1. Audit trails, shared logins and testing into compliance8 min
  2. Practice: Audit trails, shared logins and testing into compliance3 questions
Part 31Module 31Approx. 8 min
  1. Deviations, root cause and CAPA8 min
  2. Practice: Deviations, root cause and CAPA3 questions
Part 32Module 32Approx. 8 min
  1. Change control8 min
  2. Practice: Change control3 questions
Part 33Module 33Approx. 8 min
  1. Complaints, returns and salvage8 min
  2. Practice: Complaints, returns and salvage3 questions
Part 34Module 34Approx. 8 min
  1. The annual product review8 min
  2. Practice: The annual product review3 questions
Part 35Module 35Approx. 7 min
  1. Recall readiness7 min
  2. Practice: Recall readiness3 questions
Part 36Module 36Approx. 8 min
  1. Active ingredient makers: ICH Q78 min
  2. Practice: Active ingredient makers: ICH Q73 questions
Part 37Module 37Approx. 7 min
  1. Getting ready for an FDA inspection7 min
  2. Practice: Getting ready for an FDA inspection3 questions
Part 38Module 38Approx. 8 min
  1. After the inspection: 483s, warning letters, import alerts8 min
  2. Practice: After the inspection: 483s, warning letters, import alerts3 questions
Part 39Module 39Approx. 8 min
  1. The implementation roadmap8 min
  2. Practice: The implementation roadmap3 questions
Part 40Module 40Approx. 7 min
  1. Your part, and the course close7 min
  2. Practice: Your part, and the course close3 questions

Assessment & completion

Complete the learning.
Keep a verifiable record.

Learners who complete the course and its final exam receive a numbered Sterling Academy Certificate of Completion with online QR verification.

This records course completion. It does not confer ISO certification or a professional auditor qualification.

Pass mark
70%
Prerequisites
None
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