Course offering number:0906-703
Course ID:
2304
Key PAT Concepts: Focus on Design of Experiment
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help pharmaceutical industry professionals charged with enhancing and improving manufacturing efficiency for
existing drug products by using Process Analytical Technology (PAT.) Based on USFDA and EMEA guidance documents , this course helps
the user to establish a pathway to consistently high product quality. The Design-of-Experiment focus uses factorial and multivariate analysis and
arithmetic process benchmarks for SPC and EVOP control. Design-of-Experiment is an integral element of Design Space and Desired State.
It is intended for:
• PAT & QbD team members
• Tech transfer personnel
• Formulators
• Quality program managers
• New product developers
• Production managers
• Regulatory affairs personnel
• Product financial planners
• Function cross-over personnel
• In-process analysts
• Product release analysts
• Operation personnel
• Human Resource and training staff
Description
This 90-minute accredited online training course helps convert design space principles to a robust operating plan. By applying measurable
factors such as process capability index and process vs. product sigma, the course serves as a “how to” guide for converting knowledge
space into useable control elements, especially for SPC programs. The course also serves as a foundation for establishing “desired state”.
Module 1:
• Selecting your future control parameters
• Reducing the variables to a manageable few
• Applying multivariate statistics as “filters”
• Parameter detectability
Module 2:
• Partitioning the process study: Team Dynamics
• Establishing upper and lower control limits
• Cpk and Sigma
• What tools are available in ICH Q8R, Q9 and Q10?
Module 3:
• Awareness of “shadow variables”
• Simplify, simplify and then, simplify
• Using the control factors for “process signatures”
• Using process signatures and specifications for eventual
real-time release
Question and Answer Session