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This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by providing a basic overview of the most common statistical tools and terms. The course covers the use of statistical software packages and the role of software in statistical analysis and statistical process control. Areas addressed include how to use statistics to properly trend data, support the annual product review, justify process changes and set product specifications. By the end of day two, course participants will have acquired the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements. Throughout the duration of this intimate, hands-on course, participants will be able to interact with both an expert instructor and their peers.
Why you should attend:
This course will help you to use statistics correctly and minimize compliance risk.
Day 1 – Agenda
Lecture 1: Introduction and Basic Overview of Common Statistical Tools Exercise: Identify Participants' Statistical Experience and Course Goals
Lecture 2: Apply Statistics to Specification Setting
Exercise: Setting Statistical Based Specifications Lecture 3: Regression analysis and variance components
Lecture 4: Implement Design of Experiments (DOE)
Day 2 – Agenda
Exercise: Mock Experimental Design Lecture 5: Validate your Testing Methods using Statistics
Exercise: Analysis of a Method Validation Study Including Protocol Development Lecture 6: Trending Analysis
Exercise: Review and Critique a Sample SPC Control Chart Lecture 7: Design a Statistically Sound Sampling Plan
Exercise: Create a Mock Sampling Plan Lecture 8: Statistically Analyze Annual Product Review (APR) Data
Who Will Benefit:
This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies:
The employees who will benefit include:
President, Statistical Outsourcing Services
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.
DATE, VENUE & PRICE:
Location: Singapore Date: August 7th & 8th, 2014 Time: 8:30 AM to 4:30 PM
Venue Name: Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867
Venue Address: Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867
Register now and save $200. (Early Bird)
Until July 10, Early Bird Price: $1,595.00 from July 11 to August 05, Regular Price: $1,795.00
Contact Information Event Coordinator
Toll free: +65 3158-1047
Fax: 302 288 6884
Event Link - http://bit.ly/StatisticsfortheNon-Statistician
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