Equipment validation plays a critical role in ensuring that systems consistently produce high-quality pharmaceutical products. A fully qualified system is essential for maintaining operational integrity, compliance, and product safety. This training program focuses on comprehensive equipment qualification, encompassing Design, Installation, Operational, and Performance Qualification stages. These phases together provide a high degree of assurance that equipment performs reliably and as expected under defined conditions.
Participants will gain a thorough understanding of key components such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) or Continuous Qualification (CQ). The course includes hands-on instruction on developing and executing qualification protocols, test case examples, and various essential testing procedures. These include power failure tests, door open tests, temperature distribution and penetration testing, alarm testing, loaded and empty chamber mappings, and equipment calibration.
Further modules introduce advanced testing methods such as shelf mapping, vacuum testing, biological indicator tests, the Bowie-Dick test, vacuum leak testing, conductivity assessments, riboflavin removal testing, and controlled rate mapping. The program also covers the preparation of qualification and validation service reports, protocols, and SOPs, ensuring participants are fully equipped to manage documentation requirements in a GMP-compliant environment.
Learning Outcomes
Upon successful completion of this course, students will be able to understand and apply current equipment validation standards. They will be equipped to organize, implement, and manage system qualifications, write and execute validation protocols, perform audits and inspections, and contribute to ongoing process improvements in pharmaceutical environments.
Job Opportunities
This training prepares candidates for various roles in the pharmaceutical and biopharmaceutical industries, including Validation Assistant, Validation Specialist, Coordinator, and Validation Manager.
Who Should Attend
This program is designed for professionals aspiring to work in validation and quality roles, including Validation Specialists, Engineers, Process and Project Engineers, Quality Assurance and Control Specialists, Maintenance Engineers and Technicians, and Senior Validation Managers. It is particularly suited to those seeking to strengthen their expertise in equipment validation and regulatory compliance.
