Key Take Away:
This webinar will take you through how to deploy an enhanced quality metrics planning process and deal with the resistance that frequently comes with the expanded use of productivity metrics, the importance of planning for quick successes and the critical contribution made by periodic management review.
In July 2015 the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”. Much discussion of quality manufacturing metrics has ensued regarding this guidance and its elements.
This webinar provides an integrated view of the aspects of Quality Metrics including the required supporting quality culture.
Why Should You Attend:
This webinar will deepen your knowledge of Quality Metrics including the challenges, how to identify the challenges and overcoming obstacles.
The aspects of data quality metrics and the building blocks of performance metrics are also addressed. Tips, traps and recommendation on start-up are included. This strategic planning knowledge will enable the speedy implementation of a quality metrics system.
Areas Covered In This Webinar:
What are the Challenges?
• Myths of measurement
• What to measure? How to measure?
• Dealing with resistance
Uncovering the Challenges
• Review of metrics to identify opportunities for improvement
• Reviewing actions taken
• Assessing measurement and data quality
Building Blocks of Measurement Systems
• Pyramid of measurement
• Holistic measurement system
• Analysis and reporting
Tips, Traps and Getting Started
Continually improving measurement systems
• How measurement is critical to success for both industry and FDA
• How to take a Systems View of metrics
• Difference between metrics useful to FDA the broader list of metrics needed by industry to effectively run their business
• How to deal with the resistance that frequently comes with the expanded use of metrics
• How to deploy an enhanced metrics program
• Importance of planning for quick successes
• The critical contribution made by periodic management review
Who Will Benefit:
• People who Collect, Analyse and Report Quality Metrics to the FDA
• Pharma and Biotech Professionals including Scientists, Engineers, Quality Control, Quality Assurance, Researchers and Financial Analysts
• Professionals working in R&D, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs and Finance
Ronald D. Snee
Ronald D. Snee, PhD is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results.
Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also co-authored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.
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