This training program offers a step-by-step framework for pharmaceutical logistics companies to design, implement, and maintain a robust Quality Management System (QMS). Tailored for organizations managing warehouses and temperature-controlled transport, it covers all distribution activities, from receiving and storage to transportation and delivery. The curriculum consists of 15 modules, each aligned with regulatory requirements. Participants will learn to develop QMS documentation, establish qualification and validation programs, manage quality risks, and foster continuous improvement. The program aims to provide organizations with tools to protect product integrity, ensure patient safety, and maintain compliance under regulatory review.
The training program is based exclusively on authoritative regulatory documents, including the European Union Good Distribution Practice (GDP) guidelines, the United States Code of Federal Regulations Title 21 Part 205, Health Canada’s GUI-0069 guidelines for environmental control, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GDP Guide, the World Health Organization (WHO) Technical Supplements for time- and temperature-sensitive pharmaceutical products, and ISO 9001:2015 for quality management systems.
This program is designed for key personnel in pharmaceutical distribution, including Quality Assurance Managers, Responsible Persons, Operations Managers, Warehouse and Transport Supervisors, Quality Control Staff, Training Coordinators, and Internal Auditors. Participants will gain the specialized knowledge needed to fulfill their roles, maintain GDP compliance, and ensure product quality throughout the supply chain.
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
