PrimeGMP provides structured, practical, and industry-oriented training programs designed to strengthen the knowledge, competency, and GMP culture of pharmaceutical teams. Our training modules are customized for sterile, non-sterile, biotech, API, warehouse, QC, QA, engineering, and regulatory staff, ensuring your workforce operates confidently and compliantly under global standards.

1. GMP & Compliance Training

Foundational and advanced-level programs covering:

• EU GMP, USFDA, WHO, and PIC/S expectations
• Data integrity & ALCOA+ principles
• Documentation practices (GDP)
• QMS elements: Deviations, CAPA, OOS, Change Control
• Contamination control & aseptic behaviors
• Gowning and personnel hygiene

2. Validation & Qualification Training

Technical training for all validation teams:

• Equipment Qualification (DQ–IQ–OQ–PQ)
• Cleaning Validation & MACO/PDE basics
• Process Validation (PPQ)
• Aseptic Process Simulation (Media Fill)
• Thermal/Temperature Mapping
• CSV & PLC/HMI Validation
• Utilities qualification (HVAC, Water, CA/N₂, Steam)

3. Technical & Engineering Training

Skill-building for technical, production, and engineering teams:

• HVAC fundamentals & cleanroom behaviour
• Water system operation (PW, WFI, Pure Steam)
• Utility troubleshooting
• Equipment operation and line clearance
• Calibration & metrology basics
• Automation, PLC & HMI handling

4. Regulatory & Dossier Training

Specialized programs for RA and documentation teams:

• CTD/eCTD structure and submission
• Dossier compilation and publishing
• Understanding GMP expectations in regulatory filings
• How to respond to Health Authority queries
• Labeling, artwork & packaging controls

5. Audit Handling & Inspection Readiness Training

Practical coaching for facing regulators:

• How to answer auditor questions
• Do’s & Don’ts during FDA/WHO/EMA/MHRA audits
• Backroom/frontroom management
• Document retrieval and communication flow
• Preparing for customer audits
• Real-case studies & mock interview sessions

6. Customized On-Site Training

We conduct tailored training workshops depending on:

• Facility type (OSD, sterile, API, warehouse, biotech)
• Audience (operators, supervisors, managers, top management)
• Identified gaps from audits or observations
• New facility startup or during validation phase

Each training includes assessment tests, evaluations, attendance records, and certificates as required by QMS.

7. Training Material & Documentation

• SOP-aligned training modules
• PowerPoint presentations
• Case studies & practical examples
• Assessments & competency evaluations
• Training records compliant with QMS requirements

Why Choose PrimeGMP for Training?

• Trainers with hands-on GMP experience
• Practical, real-world examples (not textbook-only)
• Programs tailored to your processes & regulatory expectations
• Clear, simple teaching for operators & detailed technical depth for managers
• Comprehensive documentation for audit readiness