EPE Academy
Practical GxP, regulatory and pharmacovigilance training for pharmaceutical teams and partners.
Training built for real pharmaceutical operations.
Live online, on-site and customized corporate programs designed around practical GxP implementation, inspection expectations and risk-based decision-making — delivered by the same senior experts who run our projects.
Every course can be tailored to your products, processes and current findings — and mapped to specific roles across QA, Production, QC, Engineering, RA and Warehouse.
GMP & Quality Systems
T/01Core good-manufacturing-practice knowledge and a working quality system that survives inspection.
- EU GMP Fundamentals
- Advanced EU GMP for Manufacturing
- Good Documentation Practices (GDocP)
- Deviations, CAPA & Root-Cause Analysis
- Change Control Management
- OOS / OOT Investigations
- Quality Risk Management (ICH Q9)
- Pharmaceutical Quality Systems (ICH Q10)
Validation & Qualification
T/02From master planning to lifecycle validation of equipment, processes and analytical methods.
- Validation Master Plan (VMP) Essentials
- Equipment Qualification: DQ/IQ/OQ/PQ
- Process Validation Lifecycle (Stages 1–3)
- Analytical Method Validation (ICH Q2)
- Analytical Method Transfer
- Sterile & Aseptic Process Validation
- Hold-Time & Stability Study Design
Cleaning Validation & HBEL
T/03Toxicology-based cleaning limits, worst-case rationale and remediation of legacy programs.
- Cleaning Validation Fundamentals
- HBEL, PDE & ADE Determination
- MACO & Worst-Case Selection
- Sampling, Recovery & Analytical Methods
- Cleaning Validation Lifecycle & Monitoring
- Legacy Program Remediation Workshop
Regulatory Affairs & CTD
T/04Building and maintaining dossiers that pass technical validation and authority review.
- CTD & eCTD Dossier Preparation
- CTD Module 3 (Quality) Deep Dive
- EU Marketing Authorisation Pathways
- Variations & Lifecycle Management
- CMC Regulatory Strategy
- Responding to Authority Deficiencies
Digital GxP & Data Integrity
T/05Computerized-system validation and data governance to current ALCOA+ expectations.
- Data Integrity & ALCOA+ Principles
- Computerized System Validation (CSV/CSA)
- GAMP 5 (2nd Edition) in Practice
- Annex 11 & 21 CFR Part 11 Compliance
- Audit Trail Review in Practice
- Validating LIMS / MES / eQMS
Audits & Inspection Readiness
T/06Preparing sites, teams and suppliers to face inspectors calmly and pass.
- Preparing for an EU GMP Inspection
- Mock Inspection Workshop
- Internal / Self-Inspection Auditor Training
- Supplier & CMO Auditing
- Hosting Inspectors & Managing Findings
- Annex 1 & Contamination Control Strategy
GDP, PV & Distribution
T/07Distribution, responsible-person duties and pharmacovigilance across the supply chain.
- Good Distribution Practice (GDP)
- Responsible Person (RP) Training
- Cold Chain & Temperature Management
- Pharmacovigilance System & PSMF
- QPPV Responsibilities & Oversight
- Signal Management & Aggregate Reporting
Corporate & Custom Programs
T/08Tailored curricula for whole sites and teams, built around your products and findings.
- New-Hire GxP Onboarding Program
- Role-Based GMP Refresher Series
- Post-Inspection Remediation Training
- Train-the-Trainer for Internal QA
- Site-Specific Data Integrity Culture
- Executive Briefings for Management
Durations are indicative · all courses available as tailored in-house sessions · certificates of attendance issued
Bring your medicine to Europe, compliantly.
Tell us about your product and target markets — we’ll map the fastest compliant route to authorisation and supply.