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About

GMP Refresher is a focused, time-efficient update for experienced manufacturing, quality and operations professionals working under EU and US GMP frameworks. The course re-grounds learners in the principles that underpin Part I, Annex 1 (the 2022 sterile manufacturing revision), data integrity expectations, and the current themes seen in MHRA, FDA and EMA inspections. Worked scenarios cover deviations, OOS investigations, contamination control strategy and supplier qualification.

This course is recommended for production operators, QC analysts, QA personnel, QPs, validation teams and supervisors needing a structured GMP refresher. On completion, learners will be able to articulate current GMP themes, apply robust contamination control thinking, lead deviation and OOS responses, and interpret current inspection trends. Aligned with EU GMP Part I, Annex 1 (2022), ICH Q9 (R1), and FDA 21 CFR 210/211 expectations.

Course Syllabus

  1. Welcome to the GMP Refresher
  2. FDA inspection trends 2024-2026
  3. MHRA inspection trends
  4. EMA inspection trends
  5. How findings translate to consequences
  6. Common GMP failures
  7. ICH guidelines anchoring GMP
  8. FDA framework
  9. Key regulatory updates 2023-2026
  10. Pharmaceutical Quality System (PQS)
  11. The 10 principles of GMP
  12. Documentation principles
  13. Personnel responsibilities
  14. Premises and equipment
  15. Production and quality control

  1. What is data integrity?
  2. ALCOA+ in depth
  3. Data integrity violations
  4. Real inspection findings
  5. Preventive controls

  1. Documentation hierarchy
  2. Batch Manufacturing Records
  3. Logbooks
  4. SOPs in operational use
  5. Common documentation errors
  6. Electronic documentation

  1. Deviations
  2. Root cause analysis
  3. CAPA discipline
  4. Trending and pattern analysis
  5. Inspection findings on deviations and CAPA

  1. Process validation
  2. CPPs and CQAs
  3. Change control
  4. Equipment qualification
  5. Cleaning validation
  6. Continued Process Verification

  1. QC laboratory role
  2. Analytical method validation
  3. Out-of-Specification (OOS)
  4. Out-of-Trend
  5. Laboratory data integrity
  6. Common laboratory findings

  1. ICH Q9(R1) — Quality Risk Management
  2. Human error prevention
  3. Quality culture
  4. Senior management role
  5. Measuring quality culture
  6. Building durable quality capability

  1. Inspection types
  2. FDA inspection process
  3. Preparing for inspection
  4. During the inspection
  5. Common 483 observations
  6. Responding to findings

  1. Anatomy of GMP failure
  2. Warning letter case studies
  3. Product recall case studies
  4. Consent decrees
  5. Cross-cutting themes
  6. Lessons applied

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 EU GMP Annex 1, ICH Q9 (R1), FDA 21 CFR 210/211 and current MHRA / EMA / FDA inspection priorities, 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 GMP-experienced QPs and QA leads to ensure that learners can apply current expectations on the floor and in the QC laboratory.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...