Clinical and Quality Assurance Track: ISO 14155, ISO 19011, Design Controls, Process Validation Fundamentals Training by Tonex
Elevate clinical development and manufacturing quality with a practitioner-focused program that connects standards to daily decisions. You will translate ISO 14155 into rigorous clinical planning, apply ISO 19011 to build credible audit programs, and operationalize design controls that withstand regulatory scrutiny. We also walk through process validation so outcomes are statistically sound and reproducible. Cybersecurity intersects quality across connected devices, electronic records, and audit evidence; this course highlights controls that protect data integrity and patient safety. You will learn to embed cybersecurity-minded requirements into design histories, validation protocols, and supplier oversight to keep products trustworthy and compliant.
Learning Objectives
- Interpret ISO 14155 to plan ethical, compliant clinical investigations
- Build risk-based audit programs aligned to ISO 19011
- Implement end-to-end design controls with defensible traceability
- Develop process validation strategies using statistics and sampling plans
- Strengthen supplier quality, CAPA, and change control integration
- Produce inspection-ready documentation across the product lifecycle
- Apply cybersecurity considerations to protect clinical, quality, and device data
Audience
- Clinical Research Managers and Associates
- Quality Assurance and Quality Systems Leads
- Regulatory Affairs Specialists
- Design and Manufacturing Engineers
- Validation and Process Engineers
- Audit Program Managers and Internal Auditors
- Cybersecurity Professionals
Course Modules
Module 1 – ISO 14155 Clinical Research Essentials
- Study planning and justification
- Risk-benefit assessment methods
- Clinical investigation plan structure
- Informed consent and ethics boards
- Monitoring and data integrity
- Adverse event reporting discipline
Module 2 – ISO 19011 Audit Management Practice
- Audit program governance
- Risk-based audit scoping
- Checklists and evidence models
- Interviewing and sampling techniques
- Findings, grading, and CAPA links
- Auditor competence and calibration
Module 3 – Design Controls for Medical Devices
- User needs to design inputs
- Architectures and requirement flowdown
- Verification versus validation clarity
- DHF, DMR, DHR relationships
- Change control and re-validation
- Traceability matrices that stand up
Module 4 – Process Validation Fundamentals and Strategy
- IQ, OQ, PQ sequencing logic
- Protocols, acceptance criteria, rationales
- DOE and capability metrics use
- Sampling plans and confidence levels
- Revalidation triggers and periodic review
- Electronic records and data integrity
Module 5 – Risk Management and Documentation Rigor
- Hazard analysis and FMEA ties
- Risk controls and residual risk
- Usability and human factors links
- Requirements-test-evidence triad
- Records retention and readability
- Supplier controls and agreements
Module 6 – Integrated Quality Systems and Readiness
- CAPA effectiveness verification
- Complaint handling to postmarket
- Management review with metrics
- Readiness for notified bodies
- Cross-functional roles and RACI
- Cybersecurity in audits and DHF
Ready to align clinical excellence with robust quality and validation while safeguarding data and patient trust? Enroll now in Tonex’s Clinical and Quality Assurance Track to master ISO 14155, ISO 19011, design controls, and process validation—turning standards into reliable, inspection-ready outcomes.