PDA Fundamentals of Aseptic Processing Training Course

Please note that this training course has hands-on activities. Please wear long pants and closed-toe shoes.

The training course aims to provide participants with a deeper understanding of the fundamentals of aseptic processing by going beyond traditional learning materials.

Through data-driven presentations, interactive discussions, and real-world problem-solving in Virtual Reality, attendees will gain insights into guidelines, Warning Letters, and practical solutions for everyday job challenges. The course will cover a variety of hot topics including best practices and aseptic techniques, cleaning and disinfection, gowning, microbiology, training, and motivation of staff.

The program emphasizes a risk-based approach, utilizing Frame-by-Frame Risk Profiling technology to analyze frequent and critical hazard scenarios within each topic area. This method provides participants with a comprehensive understanding of potential risks and equips them with mitigation strategies to reduce these risks effectively.

The training course promises a lively and engaging learning experience for all attendees, blending theoretical knowledge with practical skills through interactive sessions and innovative technology. By utilizing the Virtual Reality Cleanroom Simulator to illustrate key cleanroom principles and common misbehaviors, participants will be better equipped to excel in their roles and uphold high standards in aseptic processing. They can immerse themselves in a realistic cleanroom environment to practice aseptic techniques, deepening their knowledge and skills. This hands-on experience also helps them identify and prevent potential human errors and associated risks in aseptic production.

Who Should Attend

Personnel involved in Aseptic Processing from sterile production departments such as:

• Production Management and Shop Floor Supervisors
• Qualified Persons
• QA and QC Microbiologists
• Personnel from technical departments

Learning Objectives

• Evaluate current aseptic processing procedures
• Assess potential risks of product contamination using airflow visualization techniques
• Determine the necessary components of an effective environmental monitoring program
• Examine cleanroom fill operations to ensure appropriate interventions and observations occur
• Review basic microbiology concepts and techniques for multiple aspects of aseptic processing
• Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
• Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
• Understand potential hazard scenarios within different fields of aseptic procession
• Raise awareness of individual human errors through simulator feedback
• Gain authentic cleanroom experience by exploring immersive Simulator modules in VR