FDA QSR (21 CFR Part 820) Fundamentals Training by Tonex
This course offers a comprehensive overview of the FDA Quality System Regulation (QSR) under 21 CFR Part 820. It provides participants with a clear understanding of quality system requirements for medical devices. The training covers design controls, production, CAPA, and documentation compliance. With increasing cybersecurity risks in connected medical devices, the course also examines how QSR intersects with device cybersecurity. Participants gain insights on how QSR compliance supports the security, safety, and reliability of digital health technologies, which is critical in preventing data breaches and ensuring patient trust.
Audience:
- Quality assurance professionals
- Regulatory affairs specialists
- Medical device engineers
- Compliance officers
- Product development managers
- Cybersecurity professionals
Learning Objectives:
- Understand the structure and purpose of 21 CFR Part 820
- Identify key QSR requirements for medical devices
- Interpret the role of QSR in product lifecycle management
- Explore cybersecurity implications in QSR compliance
- Apply QSR principles to improve audit readiness and product safety
Course Modules:
Module 1: Introduction to FDA QSR (21 CFR Part 820)
- Overview of FDA’s authority and QSR scope
- History and evolution of 21 CFR Part 820
- Definitions and key terms in the regulation
- Importance of QSR in medical device lifecycle
- Link between QSR and ISO 13485
- Impact of QSR compliance on market access
Module 2: Design Controls
- Requirements for design and development planning
- Design input and output documentation
- Design verification and validation
- Design review processes and records
- Design transfer procedures
- Common design control deficiencies
Module 3: Production and Process Controls
- Manufacturing process validation requirements
- Documentation of production procedures
- Inspection and testing protocols
- Equipment maintenance and calibration
- Process change control mechanisms
- Handling nonconforming products
Module 4: Corrective and Preventive Actions (CAPA)
- Identifying and documenting quality issues
- Root cause analysis approaches
- CAPA planning and implementation
- Monitoring and effectiveness checks
- Integrating CAPA with risk management
- Common pitfalls in CAPA systems
Module 5: Records and Documentation Requirements
- Device master record (DMR) elements
- Device history record (DHR) essentials
- Quality system record (QSR) structure
- Electronic records and signatures (Part 11)
- Audit trails and retention timelines
- Documentation best practices
Module 6: QSR and Cybersecurity in Connected Devices
- Overview of cybersecurity expectations in QSR
- FDA guidance on secure product development
- Risk-based cybersecurity management approaches
- Design considerations for cyber-safe devices
- Post-market cybersecurity surveillance
- QSR’s role in securing patient data
Join Tonex’s FDA QSR Fundamentals Training to master compliance and safeguard device cybersecurity. Enroll now to strengthen your regulatory readiness and product integrity.