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AtoZ Compliance
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5509

Event Description

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.

for more detail please click on this below link:

http://bit.ly/2aaSm2w

Email: referrals@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Fax: +1-516-300-1584

Don't wait to register for the Solving Statistical Mysteries - What does the FDA want? - By AtoZ Compliance. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.

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Event Details

Website: http://bit.ly/2aaSm2w...
Conference/Event Dates: 08/24/2016 - 08/24/2016
Conference/Event Hours: 1:30
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: Live Webinar- $155.00 for one participant
Audience: 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
Show Owner:AtoZ Compliance
Sponsorship: Yes
Sponsorship Details: AtoZ Compliance

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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