Location

Productivity and Quality Institute - Alexandria

Objectives

• • Becoming professional in pharmaceutical GEP.• Achieving excellence in the quality of pharmaceutical industry.• Empowering the overall pharmaceutical sector performance via (regulators, inspectors and manufacturer)

Outcomes

• Clear understanding of all regulatory bodies globally. • Acquire the principles of pharmaceuticals operations in different areas.• Deep understanding of the elements of the pharmaceutical quality systems fundamental knowledge for the pharmaceutical facility infrastructure including specification for (building and facilities, utilities, HVAC, water treatment plants. computer systems and equipment) • Achieving familiarity for all laboratory tasks from sampling, providing specification, and testing, retaining samples and data traceability.• Special focus on HVAC and water treatment plant.

Course Contents

GEP – historyMilestones in U.S. Drug Law HistoryMilestones in Europe Drug Law HistoryThe PIC/S GMP Guide GEP – StructureBuilding & FacilitiesEquipment Qualification & ValidationComputerized System ValidationCleaning, Sanitization & Sterilization systemsHVAC basics & PsychometryHVAC Processes & applicationHVAC cyclesBusiness Continuity & disaster recovery planningMaterial Storage, identification & Rotationtraceability & sourcingSalvaged/Returned goods and destruction