Learn to apply ICH Q9(R1) Quality Risk Management in everyday GMP work. Understand why QRM matters and what regulators expect, the principles and the QRM process, how to assess and control risk, and how to link QRM with CAPA and the pharmaceutical quality system. Practise basic tools, risk ranking, HAZOP, FMEA, FTA and HACCP, and see how QRM drives daily decisions.
Quality is built on the production floor. This course shows operators and supervisors how to weigh and dispense materials correctly, label materials and equipment to prevent mix-ups, use in-process controls to steer the process, stop cross-contamination, and handle reprocessing, rework and recovery the GMP way.
Everything you need to run packaging under GMP. Understand primary and secondary packaging materials, cartons, leaflets and labels, and how packaging materials are tested. Learn to set up and clear a packaging line, apply in-process controls, coding and reconciliation, qualify a blister line, and understand Blow-Fill-Seal technology.
A practical guide to sampling starting materials, packaging materials, intermediates and finished products under GMP. Learn why sampling matters, how to choose the right tools and containers, where and what to sample, how to build a sampling plan, how to take a representative sample without contaminating the material, and how to store, ship and retain samples correctly.
Protect operators and products when handling highly potent substances: why containment matters, hazard groups and personal protection, liner technology, containers, split valves and isolators, single-use technology and sampling, planning and qualifying containment, and finding weak points by measuring exposure.
Run investigations that inspectors trust: how deviations flow into the CAPA system, detection, impact assessment and triage, problem definition, root cause tools, human error and laboratory OOS investigations, CAPA plans with effectiveness checks, and clear investigation reports.
A complete, beginner-friendly introduction to Good Manufacturing Practice. Follow one fictional plant through real situations — from why GMP exists to how a released batch reaches the patient safely.
أساسيات ممارسات التصنيع الجيدة — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Why GMP Matters
- Medicines: The Basics
- Laws, Licences and Inspections
- Quality Management
- People and Hygiene
- Documentation and Data Integrity
- Premises, Equipment and Qualification
- Manufacturing and Packaging
- Quality Control and Batch Release
- Storage and Distribution (GDP)
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
How an effective PQS works end-to-end: management responsibility, resources, manufacturing operations, deviations, change control, audits, KPIs, CAPA and continual improvement.
نظام الجودة الدوائي — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Management Responsibility
- Resource Management
- Manufacturing Operations
- Evaluation I: Deviations, Changes and Audits
- Evaluation II: KPIs, CAPA and Improvement
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
Build and run a science-based microbial control program for non-sterile products: control strategy, risk assessment, objectionable organisms, testing, media, utilities, EM, trending, investigations, identification and rapid methods.
ضمان ومراقبة الجودة الميكروبيولوجية — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Microbial Control Strategy for Non-Sterile Manufacturing
- Microbial Contamination Risk Assessment
- Objectionable Microorganisms
- Acceptance Criteria and Testing Frequency
- Microbial Examination and Method Suitability
- Culture Media and Growth Promotion
- Microbiology of Utilities: Water, Air and Steam
- Environmental Monitoring in Non-Sterile Areas
- Alert Levels and Trending
- Excursions, Investigations and Data Integrity
- Identifying Microorganisms
- Microbiology of Primary Packaging
- Rapid Microbiological Methods
- Running the Micro QC Lab
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
A structured walkthrough of EU GMP Annex 1 — contamination control strategy, premises and barriers, cleanroom qualification, utilities, personnel, aseptic production, sterilisation, monitoring and APS.
تصنيع المنتجات المعقّمة — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Foundations: Scope, Principle, CCS and PQS
- Premises and Barrier Technology
- Cleanroom Qualification and Disinfection
- Equipment and Utilities
- Personnel
- Aseptic Production and Finishing
- Sterilisation and Specific Technologies — Part 1
- Sterilisation and Specific Technologies — Part 2
- Monitoring, APS and QC — Part 1
- Monitoring, APS and QC — Part 2
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.