Postgraduate Diploma in Recommendations, CAPA and Follow-up
Online 800-hour Postgraduate Diploma in Recommendations, CAPA and Follow-up. 8 modules covering ISO 9001 (clause 10.2: nonconformity and corrective action), ISO 13485 (clause 8.5.2: corrective action) and Minitab. Assigned tutor and open enrolment.
Postgraduate Diploma in Recommendations, CAPA and Follow-up — studying from Ireland
Ireland is a significant centre for medical technology and pharmaceuticals, with many international device manufacturers and a strong cluster of biomedical research in Galway, Limerick and Dublin. Biomechanics, wearable sensing and occupational health technologies are developed by companies, hospitals and research institutes such as the National University of Ireland Galway's research groups. Engineers in this area design medical devices, rehabilitation systems and safety monitoring solutions under strict regulatory requirements. Oversight comes from the Health Products Regulatory Authority and the Health and Safety Authority.
Fees for Ireland: €1,790 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Ireland
Typical roles
Questions from Ireland
Will this qualification be recognised by professional bodies in Ireland for this area?
SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body. Recognition is decided by individual employers or the relevant body. In Ireland, engineers in this field may look to Engineers Ireland for professional membership, but completing a SEIUM programme does not by itself grant membership of any body. Check requirements directly with the body concerned before enrolling.
How might this training be used by employers in Ireland working in this area?
Employers in Ireland decide for themselves how much weight to give a private online qualification. Many assess it alongside your existing experience, the final project and your portfolio. Roles in medical devices, occupational health and workplace safety may value specialist knowledge, but there is no guarantee of recognition or of any salary or promotion outcome. Ask prospective employers whether they would accept the qualification.
Can I study this alongside a full-time job, and does my employer need to fund it?
Programmes are fully online and taught in English, so you can study from home at your own pace around work. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly commitment accordingly. Fees can be paid in instalments, and employer sponsorship is possible if your company agrees. Each student is assigned a technical tutor for support.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Distinguish safety recommendations, corrections and corrective actions.
Write specific, measurable and verifiable recommendations.
Implement a CAPA system in line with quality standards.
Apply root cause analysis techniques.
Prioritise actions according to residual risk.
Verify effectiveness and close actions.
Turn findings into organisational learning.
Who it's for
- CAPA manager who wants to specialise in Recommendations, CAPA and Follow-up.
- Quality engineer who wants to specialise in Recommendations, CAPA and Follow-up.
- Operational safety technician who wants to specialise in Recommendations, CAPA and Follow-up.
- Management systems auditor who wants to specialise in Recommendations, CAPA and Follow-up.
- Continuous improvement manager who wants to specialise in Recommendations, CAPA and Follow-up.
- Safety recommendations analyst who wants to specialise in Recommendations, CAPA and Follow-up.
- Engineering or science graduates looking to enter the medical device industry.
What you'll work with
- ISO 9001 (clause 10.2: nonconformity and corrective action)
- ISO 13485 (clause 8.5.2: corrective action)
- 21 CFR Part 820 (medical device quality system)
- IATF 16949 (automotive quality)
- ICH Q10 (pharmaceutical quality system)
- Regulation (EU) 376/2014 (reporting of occurrences in civil aviation)
- ISO 45001 (clause 10.2: incidents and corrective actions)
8 modules · 800 h
1.1Role of recommendations in investigation1.2Difference between finding, cause and recommendation1.3Addressees: authorities, operators and manufacturers1.4Response obligations under Regulation (EU) 996/20101.5ICAO recommendations of global interest1.6SRIS and ECCAIRS databases1.7NTSB recommendations and their follow-up1.8Failed recommendations and lessons1.9Quality of recommendation drafting1.10Case study: analysis of recommendations following a CIAIAC report
2.1Structure: problem, action and addressee2.2SMART criteria applied to safety2.3Hierarchy of controls in the recommendation2.4Avoiding generic retraining recommendations2.5Linking to contributing factors2.6Prioritisation by risk and cost2.7Prior consultation with addressees2.8Clear and verifiable language2.9Peer review of recommendations2.10Workshop: rewriting ten defective recommendations
3.1Corrective versus preventive actions3.2CAPA process under ISO 9001 and ISO 134853.3CAPA requirements in 21 CFR 8203.4CAPA opening, triage and classification3.5Linked root cause investigation3.6Action plan with owners and deadlines3.7Immediate correction and containment3.8Verification of action effectiveness3.9Closure and file documentation3.10Practice: complete CAPA file for a nonconformity
4.1Five whys and their limitations4.26M Ishikawa diagrams4.3Cause tree and fault tree4.4Change and barrier analysis4.5Apollo cause-effect method4.6Human factors with HFACS4.7Validating causes with data4.8Common errors in causal analysis4.9Depth of analysis according to severity4.10Case study: root cause of a recurring calibration failure
5.1Risk assessment before and after the action5.2Management of change MOC5.3Risks introduced by the action itself5.4Cost-benefit analysis of measures5.5Risk matrices and ALARP5.6Temporary and permanent actions5.7Coordination with maintenance and operations5.8Communicating change to staff5.9Training associated with the action5.10Workshop: risk assessment of a procedure modification
6.1Tracking systems and action records6.2Indicators: average closure time and overdue actions6.3Escalation of delayed actions6.4Periodic management review6.5Objective evidence of implementation6.6Medium-term effectiveness verification6.7Reopening ineffective actions6.8Follow-up audits6.9Software tools for action management6.10Laboratory: action tracking dashboard in a spreadsheet
7.1Single- and double-loop learning7.2Dissemination of lessons learned7.3Trend analysis of repeated events7.4Integration into the safety management system7.5Just culture and reporting7.6Proactive and reactive indicators7.7Benchmarking between organisations7.8Learning from others' events7.9Assessing CAPA system maturity7.10Case study: diagnosis of an ineffective CAPA system
8.1Diagnosis of the current system8.2Selection of a reference event8.3Root cause analysis8.4Drafting recommendations8.5CAPA plan with owners and deadlines8.6Design of monitoring indicators8.7Effectiveness verification plan8.8Documented system procedure8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: students progress at their own pace within the intake, making it possible to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Minitab, MasterControl, Power BI, advanced Excel, in free, academic or evaluation versions. Practical work is based on real CAPA file management procedures, 8D and Ishikawa analysis, and verification of action effectiveness. Assessment is continuous per module plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Distinguish safety recommendations, corrections and corrective actions.
Write specific, measurable and verifiable recommendations.
Implement a CAPA system in line with quality standards.
Apply root cause analysis techniques.
Prioritise actions according to residual risk.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient Spanish to follow technical regulatory reading.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 800 hours spread over 6 to 8 months. That is an average of 10 to 15 hours per week, compatible with full-time work.
You work with Minitab, MasterControl, Power BI and advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM diploma upon passing the continuous assessment and the final integrating project. It is SEIUM's own training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the advanced programme. Check the recognition policy when you enrol.
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