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Training Services

Designed around quality requirements, our training programmes aim to make quality culture a natural part of operations.

Our Approach

Training that takes theory to the floor

Online and/or on-site formats tailored to your company's needs and current regulations. Content enriched with company-specific examples that bring theory to the shop floor.

Online & On-site

Flexible format.

Company-Specific

Customisable content.

Certified

Programmes with certificates of attendance.

Up-to-date Regulations

A continuously updated curriculum.

Training Programmes

A comprehensive curriculum in seven areas

GxP Trainings — Core Regulations

  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • Good Distribution Practice (GDP)
  • Good Clinical Practice (GCP)
  • EU GMP EudraLex Vol.4
  • cGMP Requirements
  • Hygiene and Sanitisation
  • Contamination Control (CCS)

Validation & Qualification

  • Qualification & Validation Processes
  • Equipment Qualification — URS, DQ, IQ, OQ, PQ
  • Process Validation (PV)
  • Cleaning Validation (CV)
  • Transport Validation (TV)
  • Computerised System Validation (CSV)
  • Continued Process Verification (CPV)
  • Preparing a Validation Master Plan

Data Integrity & Digital Systems

  • Data Integrity and ALCOA+
  • Computerised System Validation (CSV)
  • Annex 11 Requirements
  • 21 CFR Part 11
  • Audit Trail Review
  • Digital Quality Systems

Quality Management Systems

  • ISO 9001 Quality Management System
  • EXCiPACT GMP Quality Management
  • Total Quality Management (TQM)
  • Change Control System
  • Deviations and Corrective Actions (CAPA)
  • Annual Product Quality Review (APQR/PQR)
  • Preparing the Site Master File (SMF)
  • Handling Customer Complaints

Audit & Supplier Management

  • Inspection Preparation and Team Readiness
  • GxP Internal Auditor Training
  • Ready4Audit Auditor Qualification
  • Internal Quality Audit
  • Supplier Qualification
  • Recall System

Documentation & Quality Systems

  • Documentation and Archiving Systems
  • Running an Effective Training System
  • Contamination Control Strategy (CCS)
  • Internal Quality Auditor Training
  • Quality Processes with Technical Teams
  • Process Analysis and Improvement

Leadership, Management & Personal Development

  • Understanding Each Other as a Team and Focusing on the Goal
  • Teamwork and the Rules of the Game
  • Managing Stress with a Positive Mindset
  • Winning with Effective Communication
  • Making a Difference with Management Skills
  • Presentation Skills · Time Management
  • Sources of Motivation
  • Motivating the Team During Inspection Preparation
  • Work–Life Balance
  • Business Ethics and Artificial Intelligence

Let's build a training plan for your team

Let's assess your current competencies and design a modular training programme tailored to your organisation.

Request Training