ARIREX — Training & Competency
Building Competence. Reinforcing Compliance.
ARIREX delivers practical, regulation-aligned training programs that strengthen personnel competency, reinforce documentation discipline, and support a sustainable culture of quality. Our training is built by practitioners who have applied these standards on the job — not generic e-learning content.
Our Training Practice Areas
ARIREX's training practice covers seven core areas supporting personnel competency, documentation discipline, and inspection readiness across regulated organizations.
1. GMP Fundamentals Training
Foundational training on Good Manufacturing Practice principles aligned to US FDA 21 CFR 210/211, Health Canada GMP Guidelines (GUI-0001), and EU GMP (EudraLex Volume 4), tailored to manufacturing, quality, and support personnel.
Ideal for: new employee onboarding and annual GMP refresher training.
2. GDP & Distribution Compliance Training
Training on Good Distribution Practice requirements aligned to EU GDP Guidelines and Health Canada GUI-0069, covering cold-chain handling, storage conditions, and transportation controls.
Ideal for: warehouse, logistics, and distribution personnel handling regulated products.
3. SOP & Documentation Discipline Training
Training that reinforces good documentation practices, data integrity principles (ALCOA+), and SOP adherence, addressing the root cause of most documentation-related audit findings.
Ideal for: organizations with recurring documentation errors or audit findings related to record-keeping.
4. Data Integrity & 21 CFR Part 11 Training
Training on data integrity expectations under ALCOA+ and 21 CFR Part 11, covering electronic record controls, audit trail review, and common data integrity failure modes.
Ideal for: laboratory, manufacturing, and IT personnel managing electronic systems and records.
5. CAPA & Root Cause Analysis Training
Practical training on root cause investigation methodology, CAPA effectiveness checks, and closure documentation that satisfies regulatory expectations.
Ideal for: quality and manufacturing personnel responsible for investigating deviations and non-conformances.
6. Internal Auditor Training
Training to develop internal audit capability, covering audit planning, execution, evidence-gathering, and report writing aligned to ISO 9001:2015 and GMP audit expectations.
Ideal for: organizations building or strengthening an internal audit program.
7. Mock Inspection & Inspection Readiness Training
Practical preparation for US FDA, Health Canada, and EU/EMA inspections, including front-room/back-room roles, question-handling technique, and document-request response practice.
Ideal for: organizations preparing personnel ahead of an announced or anticipated regulatory inspection.
Why ARIREX for Training
Practitioner-led
Our trainers have held quality and regulatory leadership roles inside the industries they now train, bringing real inspection and audit experience into the room.
Built for retention, not just attendance
Training is designed around practical scenarios, not passive slide delivery.
Customizable
Programs are scaled and tailored to your organization's regulatory scope, team size, and maturity level.
Our Training Delivery Process
Assess
Identifying competency gaps and training priorities.
Design
Building a program scoped to your team's roles and regulatory exposure.
Deliver
Conducting on-site, virtual, or hybrid training sessions.
Assess Retention
Evaluating comprehension through practical exercises or assessments.
Reinforce
Providing refresher sessions and materials to sustain competency over time.
Ready to strengthen your team's competency?
Book a free 30-minute consultation and we'll help you identify the right training program for your organization.
Book a Consultation