2017 - Webinar on Improving Process Stability and Capability ? Tips, Traps and Guidance

Description:
FDA’s Process Validation Guidance Stage 3 calls for “ongoing assurance is gained through routine production that the process remains in a state of control.” Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. In this session “tips and traps” are discussed that enable pharmaceutical scientists and engineers to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls.
The issues discussed include: how to reduce false out of control signals, measures of process stability, how to identify causes of out of control signals, how to select the appropriate sampling procedures. The approaches and tools discussed are illustrated with pharmaceutical and biotech case studies and examples.
Areas Covered in the Session :
Reducing False Out of Control Signals
How to Use Process Stability Metrics
Selecting Appropriate Sampling Procedures
Identifying Causes of Out-of-Control Signals ? The Usual Suspects
Early Warning Devices for Detecting Process Shifts
How to Select the Right Control Chart
Can We Reduce Sampling
Assessing the Pedigree of Your Data
Tips, Traps and Guidance ? What to Watch Out For
Who Will Benefit:
Production Managers
Process and Manufacturing Engineers
Quality Assurance Managers, Scientists and Engineers
Quality Engineers
Lab Testing Personnel
Research and Development Scientists
Product Development Personnel
Biologists and Microbiologists
Chemists and Chemical Engineers
Supply Chain Professionals
Process Improvement Professionals