GxP Training & Advisory
Practical training programmes for pharmaceutical teams — tailored to your regulatory environment, equipment, and operational context.
Why GxP Training Matters
Compliance systems are only as effective as the people operating them. Well-designed SOPs and validated equipment provide no assurance if the team responsible for them does not understand the regulatory rationale, the operational requirements, or how to respond to deviations.
GxP Mentor training is designed to be practical and applicable — not a lecture on regulations, but a working understanding of how those regulations translate into day-to-day compliance decisions. We tailor all content to your environment, your products, and your team's existing knowledge level.
Training Courses
Thermal Mapping Techniques & Theory
Covers the regulatory basis for thermal mapping, sensor placement theory, study execution, data review, and reporting. Practical exercises on interpreting mapping data and identifying hotspots and coldspots.
- Why thermal mapping is required
- Regulatory framework overview
- Sensor placement logic and risk areas
- Study execution and data integrity
- Data analysis and report review
- Permanent monitoring sensor placement
Data Integrity for Pharmaceutical Systems
Covers the ALCOA+ principles, data integrity risk areas in pharmaceutical monitoring and records systems, audit trail review, and regulatory expectations across FDA, EMA, and WHO frameworks.
- ALCOA+ principles explained
- Common data integrity failure modes
- Audit trail review practice
- Electronic records requirements
- Data integrity in monitoring systems
- Responding to data integrity findings
Qualification & Validation Fundamentals
A foundational course covering the lifecycle of equipment qualification (IQ/OQ/PQ), system validation principles, protocol writing, acceptance criteria development, and deviation management.
- Validation lifecycle overview
- IQ, OQ, PQ — purpose and scope
- Writing protocols and test scripts
- Acceptance criteria development
- Deviation and CAPA management
- Requalification triggers
Good Storage & Distribution Practice
Covers GDP and GSP requirements for pharmaceutical product handling, storage condition management, temperature excursion response, and documentation expectations.
- GDP/GSP regulatory requirements
- Storage condition management
- Temperature excursion response
- Cold chain handling procedures
- Documentation and record-keeping
- Supplier and transport qualification
Training Formats
On-Site
Delivered at your facility, using your environment as context
Remote
Live virtual sessions via video conference
Tailored Workshops
Bespoke content built around your SOPs and processes
Induction Training
Structured onboarding for new GxP team members
Refresher Training
Periodic competency refreshers for existing staff
Advisory Support
Beyond formal training, GxP Mentor provides ongoing compliance advisory support for organisations managing pharmaceutical storage and distribution systems. Advisory engagements can cover gap assessments, inspection preparation, corrective action review, and technical consultation on specific compliance questions.
Advisory support is available on a project basis or as a retained service for organisations that benefit from ongoing specialist access.
Enquire About Training
Tell us about your team and we will propose a suitable programme.