PDA EU00179 Best Practices and Points to Consider in Aseptic Processing

The aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment and go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring, and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments, and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all. The training course uses also the "Cleanroom Simulator", where participants can have an authentic cleanroom experience in Virtual Reality and gain a better feel for correct aseptic techniques. Each participant can try out different topics in the VR Simulator and in this way deepen their knowledge and skills. In addition, the course uses the VR simulator to illustrate key cleanroom principles (e.g., First Air or Microbiological Contamination) and to demonstrate frequently observed misbehavior for learning purposes. Focus area of the VR-Simulator is to enhance the awareness of potential human errors and their associated risk within aseptic production. Accordingly, all simulator sessions are associated with lectures and/or exercises on potential human error in the area of interest in the course.

• Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
• Understand key requirements and challenges in parenteral production
• Understand the importance of a good quality culture within a company
• Apply the executed and presented case studies and team exercises in her/his daily job
• Get answers and interpretations about potentially unresolved questions and problems
• Gain confidence for audits
• Understand potential human errors within different fields of aseptic procession
• Raise awareness on individual human errors through simulator feedback
• Gain authentic cleanroom experience by exploring immersive Simulator modules in VR