Process Validation for Medical Devices Essentials Training by Tonex
Medical device organizations elevate safety, quality, and compliance when their processes are validated with rigor and traceability. This course walks participants through practical IQ/OQ/PQ execution, statistical sampling, software validation, and ongoing revalidation so teams can release products with confidence.
Cybersecurity is now inseparable from process integrity—validation must verify that digital controls, data flows, and connected systems remain trustworthy. You will learn how to embed cyber risk thinking into validation artifacts, ensuring evidence covers confidentiality, integrity, and availability. By the end, you will connect process capability with regulatory expectations and a sustainable lifecycle of continuous improvement.
Learning Objectives
- Explain the regulatory basis and lifecycle of process validation across IQ, OQ, and PQ
- Design sampling plans using risk and statistics to justify sample sizes and acceptance criteria
- Author validation protocols and objective evidence aligned to ISO 13485 and 21 CFR 820
- Validate software used in production and quality systems under FDA/IEC expectations
- Build change control and revalidation strategies tied to risk signals and field feedback
- Map process capability indices to release decisions and ongoing monitoring
- Integrate cybersecurity into validation, ensuring cybersecurity controls, data integrity, and access management are verified within the process
Audience
- Quality Engineers and Managers
- Manufacturing Engineers and Supervisors
- Regulatory Affairs Professionals
- Validation and Verification Specialists
- R&D and Process Development Teams
- Supply Chain and Contract Manufacturers
- Cybersecurity Professionals
Course Modules
Module 1 – Foundations of Validation
- Regulatory purpose and scope
- IQ OQ PQ principles
- Special processes definition
- Risk based thinking
- Traceability and evidence
- Roles and responsibilities
Module 2 – Protocols and Documentation
- User requirements translation
- Validation master plan
- IQ OQ PQ protocols
- Objective evidence capture
- Deviations and resolutions
- Final report structure
Module 3 – Statistics and Sampling
- Confidence and power basics
- Variable vs attribute data
- AQL and acceptance rules
- Capability indices Cp Cpk
- DOE screening for factors
- Ongoing SPC and trending
Module 4 – Software and Data Validation
- Production software inventory
- Tool validation approach
- Electronic records controls
- Audit trails and data integrity
- Backup and restore checks
- Cybersecurity access verification
Module 5 – Equipment and Process Control
- Installation qualification rigor
- Operational ranges and alarms
- Calibration and maintenance links
- Critical process parameters
- Automation and recipe control
- MSA and gage R&R readiness
Module 6 – Change and Revalidation Strategy
- Change control triage
- Impact and risk assessment
- Requalification triggers
- Supplier and CM oversight
- Post market surveillance ties
- Continuous improvement cycle
Ready to make your validation robust, audit-ready, and cyber-aware Join Tonex for Process Validation for Medical Devices Essentials Training to equip your team with actionable templates, defensible statistics, and lifecycle strategies that stand up to regulators and customers. Enroll your group today to accelerate compliant throughput without sacrificing quality.