Certified QSR Compliance Auditor (CQCRA) Certification Program by Tonex
The CQCRA program equips professionals to plan, conduct, and report FDA QSR audits across design, production, and postmarket activities. Participants learn how to evaluate design controls, CAPA effectiveness, complaint handling, supplier oversight, risk management, and validation evidence aligned with 21 CFR 820 and related guidance.
The course connects quality system outcomes with product safety, reliability, and regulatory readiness across the device lifecycle. It also addresses digital records, data integrity, and AI enabled workflows within quality systems. Cybersecurity topics include how security risks can become quality nonconformances, how secure by design practices intersect with design controls, and how incident trends inform CAPA and postmarket surveillance. The result is an auditor who can translate findings into actionable improvements and sustained compliance.
Learning Objectives
- Explain FDA QSR structure and auditor expectations
- Evaluate design controls using traceable, risk based evidence
- Assess CAPA from detection to effectiveness verification
- Review complaint handling, MDR decision trees, and timeliness
- Verify process validation, software validation, and data integrity
- Plan and execute supplier audits and follow up actions
- Describe cybersecurity impact on quality records, CAPA, and surveillance
Audience
- Quality and Regulatory Auditors
- Design Quality Engineers
- Regulatory Affairs Specialists
- Manufacturing and Process Engineers
- Compliance Managers and QA Leaders
- Cybersecurity Professionals
- Postmarket Surveillance and Risk Managers
Program Modules
Module 1: FDA QSR Foundations and Scope
- QSR structure and definitions
- 21 CFR 820 relationships
- Roles and responsibilities
- Documentation tiers and control
- Risk management integration
- Inspection readiness practices
Module 2: Design Controls and Risk Integration
- User needs and design inputs
- Design outputs and verification
- Validation with clinical context
- Risk files and ISO 14971 links
- Traceability and change control
- Design review effectiveness checks
Module 3: CAPA Systems and Effectiveness
- Data sources and signal detection
- Root cause analysis rigor
- Action planning and prioritization
- Verification of effectiveness methods
- Management review escalation
- CAPA metrics and trending
Module 4: Complaint Handling and Postmarket
- Intake, triage, and coding rules
- MDR reportability decisions
- Field actions and recalls coordination
- Feedback to risk and design files
- Trending and management reporting
- Interfaces with service and distributors
Module 5: Production, Process, and Validation
- Process control and monitoring
- Equipment qualification evidence
- Software validation and spreadsheets
- Supplier controls and criticality
- Data integrity and record retention
- Internal audit linkage to validation gaps
Module 6: Cybersecurity, Data, and Alignment
- Secure by design in design controls
- SBOM, patching, and change control
- Postmarket security surveillance inputs
- Incident to CAPA traceability
- Digital systems and audit trails
- Premarket to postmarket alignment strategy
Exam Domains
- QSR Regulatory Framework and Audit Principles
- Design Control Evidence and Traceability Assurance
- Corrective and Preventive Action Governance
- Complaint Management and Postmarket Oversight
- Process Validation and Supplier Quality Assurance
- Cybersecurity Risk Integration and Data Integrity
Course Delivery
The course is delivered through a combination of lectures, interactive discussions, hands-on workshops, and project-based learning, facilitated by experts in the field of Certified QSR Compliance Auditor CQCRA. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.
Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified QSR Compliance Auditor CQCRA.
Question Types
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria
To pass the Certified QSR Compliance Auditor CQCRA Certification Training exam, candidates must achieve a score of 70% or higher.
Advance your auditing career with CQCRA by Tonex—enroll now to master FDA QSR compliance, strengthen design control evidence, and elevate postmarket performance.