Solving Statistical Mysteries - What Does the FDA Want?

Duration: 90 Minutes
This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations.Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools 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.
Statistical Tools for Data Analysis
Instructor: Ronald D. Snee
Product ID: 506995
Objectives of the Presentation
  • Awareness and understanding of what the FDA is looking for in the use statistics
  • Awareness of mistakes pharma and biotech companies frequently make
  • Most used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc
  • Understanding of what works and doesn't work
  • Obtain information and ideas on approaches that have worked in a variety of situations
  • Problems to be on the lookout for and useful solutions
  • What are the most useful graphical and data visualization methods
Why Should you Attend
To have a complete understanding of what the FDA is requiring pharma and biotech companies to do regarding the use of statistical thinking and methods, and what statistical concepts, methods and tools can be used to satisfy the FDA requirements.

Areas Covered
Today's Reality: FDA Guidance Regarding:
  • Quality by Design
  • Continued Process Verification
  • Test Method Development
  • FDA Guidance's - Examples of Recommended use of Statistical Thinking and Methods
  • Tools, Methods and Personnel
  • What is the Appropriate Documentation?
  • What's the FDA Looking for?
  • Right Process Measurement, Data, Tools and Methods and Interpretation
  • Useful Standards
  • Understanding of tool usage and interpretation of results
  • Tips, Traps and Recommendations
Who will Benefit
  • 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
$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ron Snee is the Founder and President of Snee Associates, a firm dedicated to 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 30 years.

His recent application and research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He is a frequent speaker and has published 5 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.


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