USA Seminar 2012 at Washington Statistics for the Non-Statistician Steven Walfish by On 24th and 25th May, 2012 at Washington About GlobalCompliancePanel: GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high quality regulatory and compliance-related services. At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances, Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective experience are associated with us. Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. Net Zealous
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USA Seminar 2012 at Washington
Statistics for the Non-Statistician Steven Walfishby
On 24th and 25th May, 2012 at Washington
About GlobalCompliancePanel:
GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high
quality regulatory and compliance-related services.
At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,
Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we
have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these
sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective
experience are associated with us.
Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT
Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group
viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as
J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Net Zealous
Steven Walfish President, Statistical Outsourcing Services
USA Seminar 2012 at Washington
About Speaker: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.
May 24th and 25th, 2012 at Washington
Will be announced soon
Date and Venue:
Past Seminars
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Seminar Content: Conference timings: 9 AM PDT to 5 PM PDT
Day 1 - 5th April 2012 Day 2 - 6th April 2012
USA Seminar 2012 at Washington
Lecture 1: Introduction and Basic Overview of Common Statistical Tools
„ Types of Data
„ Data Presentation and Graphics
„ Normal Distribution
„ Introduction to Hypothesis Testing
– P-Value
– Z-Test
– T-Test
– Chi-Square
– F-Test
Lecture 2: Apply Statistics to Specification Setting
„ Setting appropriate product specifications
„ Determine FDA requirements for OOS results
„ Determine how to best investigate OOS results
„ Introduction to Interval Estimation
– Confidence Interval
– Tolerance Interval
„ Outlier Analysis
Lecture 3: Regression analysis and variance components
„ Correlation
„ Linear Models
„ Residual Analysis
„ Lack of Fit
„ Hazards of Regression
„ Multiple Regression
„ Non-linear regression (4-parameter models)
„ Analysis of stability data including shelf life estimation
Lecture 4: Implement Design of Experiments (DOE)
„ Design experiments appropriately and effectively
„ Ensure that experiments are reproducible
„ Improve process capability by reducing variability
„ Analysis of variance
– Continuous Versus Discrete
– Descriptive Versus Inferential
„ Discuss applicable software packages for use:
– Microsoft Excel - SAS
– Mini-Tab - JMP
Lecture 5: Validate your Testing Methods using Statistics
„ Analyze ICH guidelines (Q2A & Q2B)
„ Ensure robustness and ruggedness of your method
„ Develop protocols based on sound statistical methods
Lecture 6: Trending Analysis
„ Define Statistical Process Control (SPC)
„ Determine how SPC can be applied to and help your process
„ Identify the benefits of using SPC
„ Trend Analysis
Lecture 7: Design a Statistically Sound Sampling Plan
„ Create and justify your sampling plan
„ Account for sampling and measurement error
„ Determine the relationship between sample size, statistical precision, and statistical power
Lecture 8: Statistically Analyze Annual Product Review (APR) Data
„ Examine statistical techniques relevant to APRs
„ Use descriptive statistics to present the data
„ Use graphs and plots effectively
„ Interpret statistical data to identify trends and deviations
„ Quantify validation characteristics:
– -linearity -range
– -accuracy -limit of detection (LOD)
– -precision -limit of quantitation (LOQ)
„ Regression analysis and variance components
„ Analysis of Stability data.
„ Comply with FDA Requirements for Process Analytical Technology (PAT)
– Define Process analytical technologies and identify related tools
– Identify the role statistics play in the PAT framework
– Comply with the FDA’s 2004 PAT draft guidance requirements
– Process Analytical Technology
„ Define different types of sampling
– Random
– Stratified
– Composite
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
How to Register:
v Register online. Use your American Express, Visa or MasterCard
v For group discount of more than 5 attendees call 800-447-9407
v Call +1 - 800-447-9407 or Fax your PO: 302-288-6884
v Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,
6552 Palisades Dr. Centreville, VA 20121
Contact Information:Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
GlobalCompliancePanel
NetZealous
1000 N West Street,
Suite 1200, Wilmington,
DE 19801..
Kindly get in touch with us for any help or information.
Look forward to meeting you at the seminar
Team GlobalCompliancePanel
USA Seminar 2012 at Washington
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
notepad and pen.
9. Networking with industry's top notch professionals
Companies that will benefit:
† Medical Devices
† Diagnostic
† Pharmaceutical
† Biologics
Pricing List:
1. Price for One Delegate pass
$1895 (Between March 23th to April 25th)
-----------------------------------------
2. Early bird price for one Delegate pass $1695
(Between February 16th to March 22th)
-----------------------------------------
3. For discounts on multiple registrations, contact customer care at 1800 447 9407
Professionals who will benefit:
£ Development Scientists
£ Analytical Method Development
£ QA/QC Personnel.
What you get:
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