Conducting, Documenting and Reporting Statistical Analysis

Duration: 90 Minutes
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 Quality by Design and Process Analytical Technology promoted by the FDA. The Jan 2011 FDA process validation guidance has statistical thinking and methods at its core. 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 Analysis
Instructor: Ronald D. Snee
Product ID: 509011
This webinar addresses how to effectively use statistical thinking and methods in pharma and biotech studies and provides an overview of the process of planning, conducting, documenting and reporting statistical analysis. Roadmaps are provided to identify the critical steps in this process. The approaches, concepts, methods and tools are illustrated with case studies and examples for pharma and biotech studies.

Objectives of the Presentation
  • What the FDA is looking for in the use statistics
  • Awareness of the "process" of planning, conducting, analyzing, and reporting of statistical studies
  • Critical steps in planning, conducting, analyzing, and reporting of statistical studies
  • How to use visualization to analyze and report results
  • Most frequently used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc
  • What are the most useful graphical and data visualization methods
  • Tips and Traps for what works and doesn't work
  • Obtain information and ideas on approaches that have worked in a variety of situations
  • Problems and mistakes to be on the lookout for and useful solutions
Why Should you Attend
To have an overall understanding of the "process" of planning, conducting, analyzing, and reporting of statistical studies including: the critical steps in the process, how to use visualization to analyze and report results, the most frequently used statistical tools and the most useful graphical and data visualization methods. This webinar will provide the participants of what is required to successfully use statistical thinking and methods in data-based investigations.

Areas Covered
  • Use of statistical thinking and methods
  • What are the appropriate planning, conduct, analysis and documentation of statistical studies?
  • FDA guidance's - Examples of recommended use of statistical thinking and methods
  • Quality by design
  • Continued process verification
  • Test method development
  • Tools, methods and personnel
  • 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
  • Anyone who collects, analyzes and reports data as part of their work responsibilities
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • 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.


View More