Course Description

It is a regulations and guidelines issued by the international organizations such as World Health Organization WHO, American Food and Drug Organization FDA covering all inputs of the Pharmaceutical/Biopharmaceutical manufacturing process to assure the quality of the manufacturing process outputs. The course covers the following: Introductions (WHO, FDA, EU and ICH) - Food, Drug and Cosmetic Act (FDCA) - The FDA regulatory environment - Eudralex guidelines - The medical products lifecycle from discovery to post-approval - How the regulations define quality - Quality vs. Compliance - The GMP requirements include: Eudralex Volume 4 GMP Overview - Pharmaceutical quality system - Organization and responsibilities toward quality activities - Personnel - Premises and equipment design for GMP compliance - Sanitation & hygiene - Documentation system: (protocols, procedures, records and reports) - Technical writing - Quality control - Outsourced activities - Contract manufacturing and analysis- Complaints handling - Recall system