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