Date: 24-26 August 2026
Location: Egypt
Venue: Triumph Hotel (El-Khalifa El-Maamoun Street, Heliopolis, Cairo, Egypt)
Learning Objectives
- Apply Quality Risk Management (QRM) Principles: Systematically assess, control, communicate, and review risks to product quality and patient safety across the entire pharmaceutical lifecycle using science-based decision making and move from reactive end-product testing to proactive quality-by-design manufacturing by implementing the updated regulatory expectations for sterile products.
- QRM Application Examples Across Different Dosage Forms
- Solid Dosage Forms (Tablets and Capsules)
- Liquid Dosage Forms (Syrups, Suspensions, Drops)
- Semi-Solid Dosage Forms (Creams and Gels)
- Sterile Products (Aseptic and Terminally Sterilized)
Targeted Trainees
- Quality Assurance Professionals (seniors & Juniors) & internal auditors.
- .Production Engineers& production Pharmacists
- QC& QA documentation Specialists.
- Pharmacists working in R&D who are involved in the development, manufacture, testing, release and/or registration of solid oral dosage forms & Injection.
Expected Outcomes
- Lifecycle Management and Implementation Challenges.
- Contamination Control Strategy (CCS): components and importance with examples. Develop a Design and maintain a holistic, site-wide defense system that interconnects facility engineering, barrier technologies (like Isolators and RABS), utilities, and personnel behaviors to prevent contamination.
- Execute Advanced Aseptic Controls: Implement strict operational mandates, dynamic airflow visualization, and Pre-Use Post-Sterilization Integrity Testing (PUPSIT).
- Drive Continuous Improvement and CAPAs: Use post-marketing surveillance, customer complaints, and environmental deviation trends to continually review risks and implement effective Corrective and Preventive Actions (CAPAs).
Trainer’s Profile:
Dr. JOSEPH ALBAIR MASSOUD with 25 years of progressive experience in Oral Solid Dosage (OSD) manufacturing within regulated Egyptian and multinational pharmaceutical environments. Extensive expertise in cGMP compliance (WHO, FDA & EU GMP), SAP ERP production planning, operational excellence, Lean manufacturing, OEE optimization, CAPEX/OPEX control, and quality risk management. Proven leader with a strong track record in delivering production plans, leading audits, developing high-performing teams, and driving continuous improvement.
Training Agenda:
Day 1
- Introduction
- Development of Quality concepts
- Difference between Risk and hazard
- Applications of QRM in material sourcing and supplier selection
- Applications of QRM in different stages of OSD manufacturing
- Group inquiries, discussion& Quiz
Day 2
- Case study to review QRM in OSD
- Applications of QRM in Liquids and Semi-solid products manufacturing steps
- FMEA example with calculation base
- Case study
Day 3
- Annex 1 of sterile manufacturing – Comparison between old and current versions
- CCS pillars and examples – Practical example
