Capabilities
Designed for Modern Validation Engineering Environments
This program helps participants develop a structured understanding of validation workflows, regulatory expectations, and risk-based documentation practices used in highly regulated manufacturing.
Validation Lifecycle
Complete understanding of the flow from user requirements to continuous process verification.
Risk-Based Validation
Integration of ISO 14971 principles into technical rationale and validation strategies.
Validation Documentation
Developing audit-ready objective evidence and technical rationale for regulated environments.
Technical Rationale
Scientific justification for sample sizes, test methods, and acceptance criteria.
Objective Evidence
Ensuring data integrity and robust evidence during the entire manufacturing lifecycle.
Cross-Functional Alignment
Bridging communication gaps between engineering, quality, and production teams.
Compliance
Regulatory & Validation Scope
The program introduces participants to modern validation expectations across regulatory, engineering and operational environments. We align technical work with the highest industry standards.
Integrated Validation Lifecycle
Participants learn how validation activities connect across the full lifecycle of regulated manufacturing.
Contextualized for Electronics Manufacturing
Program Structure
A modular approach to mastering validation engineering.
Governance & Framework
2 Hours
- FDA Process Validation Guidance & ISO 13485
- Validation Lifecycle Map & URS/FAT/SAT
- Documentation standards and Data Integrity
Deliverables
Validation documentation map, Governance checklist.
Foundations & Context
2.5 Hours
- Risk-based thinking and impact on Patient Safety
- Objective evidence fundamentals
- Regulatory perspective on common findings
Deliverables
Validation risk map.
IQ: Installation Qualification
3.5 Hours
- Critical installation requirements & SAT integration
- Traceability and criticality assessment
- App: Reflow ovens, AOI, Pick & Place
Deliverables
IQ checklist, Protocol template, Criticality matrix.
TMV: Test Method
3.5 Hours
- Repeatability, Reproducibility and Reliability
- Attribute agreement and validation decisions
- App: Visual inspection, Electrical testing
Deliverables
TMV evaluation matrix, Practical guide.
OQ: Operational Qual.
5 Hours
- Process characterization and DOE concepts
- Statistical rationale and sample size fundamentals
- App: Wave solder, Adhesive dispensing
Deliverables
Critical parameters matrix, OQ protocol structure.
PQ: Performance Qual.
5.5 Hours
- Process capability (Cp, Cpk, Pp, Ppk) and stability
- Introduction to Continuous Process Verification (CPV)
- App: SMT lines, FPY, Solder joint consistency
Deliverables
PQ design checklist, PQ review guide.
TRAAC® Applied Learning Methodology
The program combines technical instruction, practical workshops, mentoring and continuity-focused learning to maximize real-world application.
VOC & Design
Understanding customer needs and defining the program roadmap.
VOP & Leveling
Voice of process and identifying baseline capabilities of participants.
Setup & Kick-off
Final alignment and program launch with practical toolsets.
RUN & Delivery
Core execution with applied workshops and case studies.
Continuity Focused
Learning doesn’t end with the course. We provide LMS support, coaching, and a professional community.
LMS Support
Coaching
Applied Workshops
Community
Build Strong Validation Foundations
Help your teams understand the validation lifecycle, strengthen documentation practices and develop stronger technical judgment for regulated manufacturing environments.