Course offering number:0910-704
Course ID:
2322
Key PAT and QbD Concepts: Quality Systems Integration Strategies (QSIS)
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) and for product developers whose organizations will benefit from Quality
by Design (QbD.) The course will help develop synergy between GMP and PAT, enhance risk management and effect incorporation of
production efficiency methods such as Six Sigma and LEAN. 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
• Unit operations staff
• Business planners
• Human Resource and Training staff
Description
This 90-minute accredited training course knits PAT and QbD concepts into a useful and relatively seamless evolution within your existing
quality assurance system. Its modules show how to avoid “throwing the baby out with the bath water” mistakes that have hindered adoption of
dynamic process control in quality-based dosage form manufacturing. It also explains the roles of ICH documents Q8, Q9 and Q10 as
enhancers of emerging Quality-by-Design product planning.
Module 1:
• PAT and QbD regulatory interaction
• Fitting cGMP into the program
• Defining PAT & QbD program elements
• What outcomes should you expect?
Module 2:
• Process and product-intermediate control: Process
Signatures, Parametric Release
• Examining SOP's for overlap and effectiveness in dynamic
control
• Acceptable risk when using PAT and QbD approaches
• LEAN-Six Sigma: what roles can they play? What should
they contribute?
Module 3:
• Benchmarking and goal establishment
• Detailed guide to the resources that you will need
• Relating results to the “big picture”
• Using Technology Transfer concepts to enhance PAT and
QbD programs
Question and Answer Session