Wednesday March 13, 2024
12:00 Noon – 1:30 pm (NY Time)
Instructor: Ronald D. Snee, PhD
Pharmaceutical industry is experiencing a growing need to improve performance driven by global competition and the increasing impact of information technology. Central to this need is good data, a characteristic of good science. Quality data are arguably more important today than ever before. It is becoming widely accepted that data are a corporate asset. The industry is also focusing on risk assessment and reduction as evidenced by FDA’s focus on data integrity.
Methods and tools widely used in test method development are discussed with emphasis on how these tools reduce risk in method development, validation and use. Methods discussed include method repeatability and reproducibility, method robustness and test method performance verification. Methods for assessing that amount of product variation that can be attributed to the manufacturing process, sampling procedures and test method are also presented. A system for effectively using management review to increase the sustainability of the risk-based approaches is also presented and illustrated with pharmaceutical and biotech case studies and examples.
Topics discussed include:
Part 1 – A Look at Today’s Realities
· Importance and need to improve measurement integrity and quality
· Need to Reduce Risk in method validation
· The Promise of Quality by Design (QbD) – Building Quality into Test Methods
· Understanding measurement processes
Part 2 – Methods for Reducing Risk in Method Validation
· Test method development using designed experiments
· Measurement quality – Repeatability and reproducibility
· Improving test method robustness
· Measurement process control – Continued process verification
Part 3 – How to Troubleshoot Measurement Test Methods
· Is the variation due to sampling method or test method?
· Using designed experiments to quantify variation
· Using data to identify opportunities for improvement
· Graphical methods to visualize and understand variation
Takeaway Tools
Tips and traps for test method development, validation, and improvement
Risk-Based Techniques for improving test method performance.
Systems approach to assess and reduce the risk associated with test method verification.
Case studies and examples of all methods presented.
Who Would Benefit
- Quality, Manufacturing and R&D Managers
- Quality Engineers
- Quality Control and Assurance Personnel
- Research and Development Scientists
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Process and Manufacturing Engineers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-578