FDA Based Guidelines on Statistical Sampling Plans
About This Event
Overview:
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.
Who will benefit:
This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies:
• Medical Device
• Diagnostic
• Supervisors
• Pharmaceutical
• Biologics fields
The employees who will benefit include:
• Development Scientists
• Analytical Method Development
• QA/ QC personnel
Why you should attend:
This course will help you to use statistics correctly and minimize compliance risk.
Course Outline/ Agenda:
Day One:
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
Lecture 3: Regression analysis and variance components
Lecture 4: Implement Design of Experiments (DOE)
Day Two:
Lecture 5: Validate your Testing Methods using Statistics
Lecture 6: Trending Analysis
Lecture 7: Design a Statistically Sound Sampling Plan
Lecture 8: Statistically Analyse Annual Product Review (APR) Data
Instructor/ Speaker Profile:
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, Time and Venue:
Location: Singapore
Time: 8:30 AM to 4:30 PM
Date: August 7th & 8th, 2014
Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867
Venue/Hotel Phone Number: (65) 6235 7788
Price: $1595.00
Discount: 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
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Please call any of our representatives on 1800 447 9407 to help you completed the transfer.
Contact Information:
John Robinson
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
Website: https://www.globalcompliancepanel.com
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