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About

The Quality Risk Management (QRM) in GMP training course by Whitehall Training provides a comprehensive foundation in ICH Q9 principles and their application within the pharmaceutical industry. Spanning approximately 6-8 hours, the programme is designed for professionals in QA, Regulatory Affairs, Manufacturing, and R&D. It covers the essential QRM process—comprising risk assessment (identification, analysis, and evaluation), risk control, communication, and continuous review. Key methodologies explored include Failure Mode & Effects Analysis (FMEA), Hazard Analysis & Critical Control Points (HACCP), and Fault Tree Analysis (FTA). The course emphasizes science-based decision-making and proportionality, ensuring that the level of effort and documentation reflects the level of risk to the patient. By integrating practical case studies, such as tablet compression and sterile manufacturing, the training demonstrates how QRM facilitates continuous improvement and regulatory compliance across the entire product lifecycle.

Course Syllabus

  1. Why Quality Risk Management?
  2. Formal & Informal Risk Management Processes

  1. Primary Principles of QRM (ICH Q9)
  2. Secondary Principles of QRM

  1. The QRM Process — ICH Q9 Framework
  2. Risk Assessment — A Closer Look
  3. Risk Control & Risk Communication

  1. QRM Tools — ICH Q9 Recognised Methods
  2. FMEA — Failure Mode & Effects Analysis
  3. FMEA in Tablet Compression: Controlling Weight Variation
  4. The Risk Matrix — Visualising Risk

  1. QRM in Commercial Manufacturing
  2. HACCP Applied to Sterile Manufacturing — Contamination Control
  3. QRM in Product Development — Risk-Based Design
  4. Risk-Based Process Validation — Oral Solid Dosage Form

  1. QRM in Compliance Inspections
  2. QRM in Inspection Planning & Risk Assessment
  3. QRM in Dossier Review & Regulatory Submissions
  4. QRM in a GMP Inspection — Turning Risk into Compliance Confidence
  5. QRM in Practice — Common Mistakes to Avoid

Course Benefits

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Fully compliant

This course follows the guidance of Annex 13 of the European Commission's GMP guidelines

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Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

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Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

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Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

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Reliable and trustworthy

This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

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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...

SM

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...