PDA 257 Risk-Based Approaches to Achieve Effective Training and Holistic CCS Success

Health authorities and guidelines suggest that a holistic CCS to ensuring safety in manufacturing processes is essential, which should be based on differentiated data and proper risk assessment. This means that a risk-based approach to the fundamentals of aseptic processing, as well as specific processes, is critical to developing effective training and standard operating procedures (SOPs).

This training course is divided into four parts:

• The first part focuses on how to create a risk-based training approach for fundamentals of aseptic processing. Examples are provided to illustrate how risk-based learning objectives can be developed and used to guide curriculum design and assessment/qualification programs for cleanroom operators. Participants will also get hands-on experience with a Virtual Reality Cleanroom Simulator.
• The second part introduces “Frame-by-Frame Risk Profiling” as a novel approach to identify possible errors within specific aseptic manufacturing processes. Participants will learn how the "process frame library" was used in previous projects to categorize and understand specific risks in aseptic manufacturing.
• The third part of the training course focuses on using risk profile data to develop effective training exercises and SOPs for specific processes, with the goal of improving operator training and risk management.
• The final part of the training course shows how the risk profile-based approach can be used to provide a compelling rationale to health authorities for staff training and SOPs as part of a holistic CCS.