Training & Qualification

Training as a compliance pillar

Human error remains one of the most frequent root causes of deviations and quality incidents in regulated industries. Most data integrity problems, inadequate validation or SOP non-compliance originate from insufficient or inadequate training.

Regulators know this. The FDA and EMA expect regulated organisations to have documented, effective and up-to-date training programmes that ensure personnel performing critical operations understand the applicable requirements and the risks associated with non-compliance.

Training areas

GxP and regulatory requirements

Training in the fundamentals of the GxP system (GMP, GLP, GCP, GDP), the regulatory principles applicable to each function and the impact that daily activities have on the organisation's regulatory compliance.

System validation (CSV/CSA) and GAMP 5

Specialised programmes for validation, quality and IT teams who need to understand system lifecycle requirements, the practical application of GAMP 5 (second edition) and the Computer Software Assurance approach.

Data integrity and ALCOA+

Practical training on what data integrity is, why it matters and how to apply ALCOA+ principles in daily work. Particularly useful for operators, laboratory analysts and production personnel.

21 CFR Part 11 and EMA Annex 11

Specific requirements for the use of electronic records and electronic signatures in regulated environments. Aimed at IT, quality and compliance teams implementing or auditing these systems.

Inspection readiness training

Preparation of personnel to interact with FDA, EMA or national agency inspectors. Includes inspection simulations, back-room management and effective communication during a regulatory visit.

Training modalities

• On-site in-company: At your premises, adapted to your actual processes and systems.
• Live online: Synchronous sessions via videoconference with interaction and practical cases.
• Asynchronous e-learning: Self-paced modules with assessment and completion records.
• Practical workshops: Exercises based on real industry cases, simulated audits and document analysis.

Materials and documentation

All our programmes include up-to-date educational materials, industry case studies and, where applicable, a certificate of attendance. Training records are provided in a format compatible with GxP documentation requirements.

Ongoing training and regulatory updates

GxP regulations are constantly evolving. We offer periodic update services to keep your team current with the latest regulatory changes relevant to their function: new FDA guidance, Annex 11 updates, ICH changes or new EMA expectations.