Key Take Away:

To learn 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 that can be used to satisfy the FDA requirements.

Overview:

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.

Why Should You Attend:

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.

Areas Covered In This Webinar:

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

Learning Objectives:

• Awareness and understanding of what the FDA is looking for in the use statistics

• Understanding of what works and doesn’t work

• Obtain information and ideas on approaches that have worked in a variety of situations

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

Speakers Profile:

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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