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Webinar on Improving Process Stability and Capability – Tips, Traps and Guidance

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Category ASQ, Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices, Statistical

Deadline: February 09, 2017 | Date: February 09, 2017

Venue/Country: Online, Canada

Updated: 2016-12-19 22:51:06 (GMT+9)

Call For Papers - CFP

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

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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