Training Courses Available

QMS Fundamentals - ISO 9001 • ISO 13485 • AS9100

• Covers the structure of an effective Quality Management System, including process approach, process mapping, quality objectives, roles, responsibilities, and process ownership.

• Reviews QMS documentation, document control, records, procedures, work instructions, management review, internal audits, corrective actions, and continual improvement requirements.

• Helps teams understand how to simplify the QMS, improve process consistency, strengthen compliance, and align quality activities with business and customer requirements.

Regulatory Compliance - FDA QMSR • MDSAP • EU MDR • ISO 19011

• Covers key regulatory and audit expectations for regulated industries, including quality system requirements, inspection readiness, audit evidence, compliance gaps, and management responsibility.

• Reviews how regulatory requirements connect to documentation, risk management, CAPA, supplier controls, validation, production controls, complaints, and post-market expectations.

• Helps teams prepare for customer, certification, regulatory, and third-party audits by improving readiness, closing gaps, and strengthening practical compliance implementation.

Risk Management // ISO 14971 • dFMEA • pFMEA

• Covers product and process risk management, including hazard identification, risk evaluation, risk controls, residual risk, risk review, and risk-based decision-making.

• Reviews dFMEA and pFMEA structure, severity, occurrence, detection, risk priority, action planning, control effectiveness, and cross-functional FMEA facilitation.

• Helps teams connect risk management to design, suppliers, validation, production controls, nonconformances, CAPA, complaints, and continuous improvement.

Supplier Management // Supplier Qualification • Supplier Audits • SCAR

• Covers supplier qualification, approval, risk classification, supplier monitoring, scorecards, incoming quality performance, supplier development, and supplier change control.

• Reviews supplier audit planning, audit checklists, audit execution, audit reporting, findings, follow-up actions, SCARs, and supplier corrective action effectiveness.

• Helps organizations reduce supplier-related defects, improve supplier accountability, strengthen incoming quality, and manage supplier risk based on performance and criticality.

Validation & Cleanroom Control - IQ/OQ/PQ • ISO 14644

• Covers process validation and equipment qualification, including validation planning, user requirements, IQ/OQ/PQ protocols, acceptance criteria, reports, deviations, and revalidation triggers.

• Reviews cleanroom qualification, environmental monitoring, contamination control, gowning behavior, cleanroom classification, excursions, investigations, trending, and preventive actions.

• Helps teams maintain validated processes and controlled environments, reduce contamination risk, improve audit readiness, and support consistent product quality.

Production Control & Statistical Methods - SPC • MSA • Control Plans

• Covers production controls, control plans, process parameters, inspection points, acceptance criteria, sampling, measurement systems, and manufacturing process monitoring.

• Reviews SPC, control charts, process variation, process stability, MSA, Gage R&R, process capability, trend analysis, and practical statistical decision-making.

• Helps teams use data to reduce variation, prevent defects, improve process control, lower scrap and rework, and strengthen manufacturing performance.

CAPA & Problem Solving - CAPA • RCA • 8D • Fishbone • 5 Whys • COPQ

• Covers nonconformance management, containment, correction, disposition, escalation, root cause analysis, CAPA planning, and effectiveness verification.

• Reviews practical problem-solving tools including 8D, Fishbone, 5 Whys, process analysis, human error reduction, mistake-proofing, and cost of poor quality.

• Helps teams move from quick fixes to sustainable corrective actions, prevent recurrence, reduce repeat issues, and improve quality performance.

Continuous Improvement // Lean Six Sigma • DMAIC • Kaizen • 5S • PDCA

• Covers Lean Six Sigma principles, DMAIC, Kaizen, 5S, PDCA, visual management, waste reduction, standard work, and practical improvement planning.

• Reviews how to identify waste, define problems, analyze root causes, implement improvement actions, track results, and sustain performance gains.

• Helps teams improve efficiency, reduce waste, engage employees, strengthen process discipline, and build a culture of continuous improvement.