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Validity : 22nd Apr'24 to 02nd May'24
Solving Statistical Mysteries – What Does FDA Want?
1. Today’s Reality: FDA Guidance Regarding:
- Quality by Design
- Continued Process Verification
- Test Method Development
2. Comments on Use of Statistical Thinking and Methods from FDA Warning Letters and Presentations
- Rationale, Tools, Methods and Personnel
- What is the Appropriate Documentation
3. What’s the FDA Looking for
- Right Process Measurement, Data, Tools and Methods and Interpretation
- Useful Standards
4. Understanding of tool usage and interpretation of results
5. Tips, Traps and Recommendation
Overview of the webinar
Use of statistics has been part of the FDA’s guidance and regulations for many years. Use of statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.
This presentation provides an overview of what it appears the FDA is looking for in the use of statistics including examples and recommended approaches.
Who should attend?
- Executives and Managers of Pharma and Biotech Companies
- Process and Manufacturing Engineers
- Quality Assurance Personnel
- Regulatory Affairs Professionals
- Quality Control Lab Personnel
- Quality Engineers
- Research and Development Scientists
- Biologists and Microbiologists
- Chemists and Chemical Engineers
Why should you attend?
- What is good statistical practice as suggested by the FDA
- Importance of developing a rationale for use of statistical procedures
- Value of using selected procedures according to the protocol
- Critical aspects of using statistical methods in a regulated environment including
1. Documented procedures that include rationale for use
2. Appropriate personnel trained on the procedures
3. Access to appropriate validated software
4. Use appropriate consensus standards
5. Show that management supports all procedures used
6. Focus on the practical significance of trends and shifts and identifying meaningful, useful results
- Guiding principles, tips and traps for the effective use of statistical thinking and methods
Faculty - Mr.Ronald Snee
Ron Snee 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 approaches that produce bottom-line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career, he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical clinical trial design and analysis. He has developed and applied process design, improvement, monitoring and control methodologies for more than 40 years.
His recent application and research on QbD have produced eight articles on the use of QbD in Pharma and Biotech. He has also co-authored 3 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. Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.
He is an Honorary Member of the American Society for Quality and has been awarded ASQ’s Shewhart, Grant and Distinguished Service Medals, and the American Statistical Association’s Deming Lecture, Dixon Consulting Excellence and Hahn Quality and Productivity Achievement Awards as well as numerous other awards and honors. He is an academician in the International Academy for Quality and Fellow of ASQ, ASA and the American Association for the Advancement of Science. He is a frequent speaker and has published 7 books and more than 300 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.