Postgraduate Diploma in Audits, CAPA and Clinical Change Control
Online 800-hour Postgraduate Diploma in Audits, CAPA and Clinical Change Control. 8 modules covering ISO 13485 (quality management systems for medical devices), ICH E6(R3) (good clinical practice) and Veeva Vault QMS. Assigned tutor and enrolment open.
Take the controls.
Run a real engineering trade-off from this programme. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Describe the structure of a quality system in regulated clinical environments.
Plan and conduct clinical and quality audits.
Manage non-conformities using risk classification criteria.
Apply root cause analysis tools to define effective CAPA actions.
Implement a change control procedure with impact assessment.
Ensure data integrity in line with ALCOA+ principles.
Prepare the organisation for inspections by health authorities.
Who it's for
- Quality assurance specialist who wants to specialise in Audits, CAPA and Clinical Change Control.
- GxP auditor who wants to specialise in Audits, CAPA and Clinical Change Control.
- CAPA manager who wants to specialise in Audits, CAPA and Clinical Change Control.
- Change control coordinator who wants to specialise in Audits, CAPA and Clinical Change Control.
- Data integrity specialist who wants to specialise in Audits, CAPA and Clinical Change Control.
- Regulatory affairs technician who wants to specialise in Audits, CAPA and Clinical Change Control.
- Engineering or science graduates looking to enter the pharmaceutical industry.
What you'll work with
- ISO 13485 (quality management systems for medical devices)
- ICH E6(R3) (good clinical practice)
- ICH Q10 (pharmaceutical quality system)
- 21 CFR Part 820 (quality system regulation)
- 21 CFR Part 11 (electronic records)
- EU GMP Annex 11 (computerised systems)
- ISO 19011 (auditing management systems)
8 modules · 800 h
1.1ISO 13485 for medical devices1.2ICH E6 good clinical practice1.3Quality systems in clinical research1.4Regulation (EU) 2017/745 and quality requirements1.5Regulation (EU) 536/2014 on clinical trials1.6Controlled document management1.7Roles: sponsor, investigator and CRO1.8Quality culture1.9Risk-based quality1.10Case study: quality system map of a medical wearables manufacturer
2.1Types of audit: internal, supplier and site2.2ISO 19011 for audits2.3Audit planning and programme2.4Audits of research sites2.5Notified body audits2.6AEMPS inspections2.7Interview and sampling techniques2.8Writing findings2.9Following up findings2.10Practice: audit plan for a clinical trial site
3.1Identification and recording3.2Classification by criticality3.3Immediate containment3.4Protocol deviations3.5Customer and user complaints3.6Post-market surveillance data3.7Trends and statistical analysis3.8Notification to authorities3.9Link with ISO 14971 risk management3.10Workshop: recording and classifying protocol deviations
4.1CAPA process according to ISO 134854.2Root cause analysis: Ishikawa and five whys4.3Fault tree analysis4.4Action plans and owners4.5Effectiveness verification4.6CAPA closure and documentation4.7Software-related CAPAs4.8CAPA system indicators4.9Common errors found in inspections4.10Practice: complete CAPA for a sensor failure
5.1Change control process5.2Regulatory impact assessment5.3Significant changes under MDCG 2020-35.4Changes to software devices5.5Changes in clinical trials: amendments5.6Validation and verification of changes5.7Notification to the notified body5.8Changes to critical suppliers5.9Records and traceability5.10Case study: change control for device firmware
6.1ALCOA+ principles6.2Electronic systems and 21 CFR Part 116.3Validation of computerised systems: GAMP 56.4Audit trail and its review6.5Electronic signatures6.6Backup and archiving6.7Data integrity of wearables in studies6.8Access management6.9Common data integrity findings6.10Laboratory: audit trail review of an eCRF
7.1Organisational preparation7.2Document room and back room7.3Handling inspector requests7.4Responding to findings and action plans7.5FDA inspections and Form 483s7.6Lessons from warning letters7.7Mock audits7.8Staff training7.9Post-inspection improvement7.10Case study: responding to inspection findings
8.1Organisation description8.2Quality system analysis8.3Audit programme8.4Non-conformity procedure8.5CAPA procedure8.6Change control procedure8.7Data integrity plan8.8System indicators8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the intake, making it easier to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software includes Veeva Vault QMS, MasterControl, TrackWise, Minitab, in free, academic or evaluation versions. Case studies use real procedures for site and supplier audits, root cause analysis and regulatory inspection simulations. Assessment is continuous, module by 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.
Describe the structure of a quality system in regulated clinical environments.
Plan and conduct clinical and quality audits.
Manage non-conformities using risk classification criteria.
Apply root cause analysis tools to define effective CAPA actions.
Implement a change control procedure with impact assessment.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient Spanish to follow technical regulatory texts.
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 comprises 800 hours in total, spread over 6 to 8 months. That is an average of 10 to 15 hours per week, compatible with a full-time job.
You will work with Veeva Vault QMS, MasterControl, TrackWise and Minitab. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A SEIUM Institute own diploma upon passing the continuous assessment and the final integrating project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the advanced programme. Check the recognition policy when you enrol.
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