Quality Risk Management (QRM) for Pharmaceuticals – ICH Q9(R1)
Apply quality risk management in line with ICH Q9(R1). Participants learn the QRM process and tools – FMEA, risk ranking, cause-and-effect matrices – integrate QRM into the pharmaceutical quality system, and understand what inspectors expect.
At a glance
- 2 days · Classroom or live virtual
Who it's for
- Development, manufacturing, QA, QC, engineering, validation, regulatory affairs, pharmacovigilance and distribution staff
- Medical device, biopharma & biotech professionals; regulators
Learning objectives
- Understand the QRM process (ICH Q9(R1)) and regulatory expectations
- Evaluate your QRM system against current expectations
- Run a risk exercise: team, assessment, control, communication, review
- Use FMEA, risk ranking, cause-and-effect matrix, fishbone and process maps
- Understand how heuristics, subjectivity and culture affect risk decisions
- Link QRM to CQAs, CPPs and control strategy; document rationale in risk registers
Detailed content
- Definitions, concepts, principles & elements
- Roles & responsibilities
- Regulatory overview (ICH Q9(R1), EU GMP Part III, PIC/S)
- QRM process: identification, assessment, control, communication, review
- QRM tools: what to use and when
- Case studies
- Integration in the PQS (ICH Q10)
- QRM in GMP/GDP environments
- Subjectivity, formality & QRM culture
- Policy, SOPs, risk registers & reports
- Applying QRM to deviations, complaints, CAPA & change control
- Common pitfalls & inspectors' expectations
- Case studies
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- QRM Fundamentals
- QRM in the Pharmaceutical Quality System
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Mock regulatory inspection of a GMP area
- Deviation and CAPA case study with root cause
- Write a qualification/validation protocol outline
- Case studies from Egyptian and Gulf organizations
Tools and templates you keep
- Deviation, CAPA and change-control forms
- Validation master plan outline
- Course workbook and slide handouts
- Templates and checklists used in the exercises
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- EU GMP / PIC/S Guide; WHO GMP
- ICH Q8–Q10, 21 CFR 210/211
- Egyptian Drug Authority (EDA) guidelines
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
Frequently asked questions
How long is Quality Risk Management (QRM) for Pharmaceuticals – ICH Q9(R1)?
The program runs 2 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- GMP in Pharmaceutical Laboratories2 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 days
- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.