Net Zealous
USA Seminar 2012 at Washington
Statistics for the Non-Statistician
by Steven Walfish
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 (c) GlobalCompliancePanel.

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USA Seminar 2012 at Washington
Steven Walfish
President, Statistical Outsourcing Services
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.
Past Seminars
Date and Venue:
May 24th and 25th, 2012 at Washington
Will be announced soon

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USA Seminar 2012 at Washington
Seminar Content: Conference timings: 9 AM PDT to 5 PM PDT
Day 1 - 5th April 2012
Day 2 - 6th April 2012
Lecture 1: Introduction and Basic Overview of Common
Lecture 5: Validate your Testing Methods using
Statistical Tools
Statistics
Types of Data
Analyze ICH guidelines (Q2A & Q2B)
- Continuous Versus Discrete
Ensure robustness and ruggedness of your method
- Descriptive Versus Inferential
Develop protocols based on sound statistical methods
Data Presentation and Graphics
Quantify validation characteristics:
Normal Distribution
- -linearity -range
Introduction to Hypothesis Testing
- -accuracy -limit of detection (LOD)
- P-Value
- -precision -limit of quantitation (LOQ)
- Z-Test
Regression analysis and variance components
- T-Test
Analysis of Stability data.
- Chi-Square
- F-Test
Lecture 6: Trending Analysis
Discuss applicable software packages for use:
Define Statistical Process Control (SPC)
- Microsoft Excel - SAS
Determine how SPC can be applied to and help your
- Mini-Tab - JMP
process
Identify the benefits of using SPC
Trend Analysis
Lecture 2: Apply Statistics to Specification Setting
Comply with FDA Requirements for Process Analytical
Setting appropriate product specifications
Technology (PAT)
Determine FDA requirements for OOS results
- Define Process analytical technologies and identify
Determine how to best investigate OOS results
related tools
Introduction to Interval Estimation
- Identify the role statistics play in the PAT framework
- Confidence Interval
- Comply with the FDA's 2004 PAT draft guidance
- Tolerance Interval
requirements
Outlier Analysis
- Process Analytical Technology
Lecture 3: Regression analysis and variance
Lecture 7: Design a Statistically Sound Sampling Plan
components
Define different types of sampling
Correlation
- Random
Linear Models
- Stratified
Residual Analysis
- Composite
Lack of Fit
Create and justify your sampling plan
Hazards of Regression
Account for sampling and measurement error
Multiple Regression
Determine the relationship between sample size,
Non-linear regression (4-parameter models)
statistical precision, and statistical power
Analysis of stability data including shelf life estimation
Lecture 8: Statistically Analyze Annual Product Review
Lecture 4: Implement Design of Experiments (DOE)
(APR) Data
Design experiments appropriately and effectively
Examine statistical techniques relevant to APRs
Ensure that experiments are reproducible
Use descriptive statistics to present the data
Improve process capability by reducing variability
Use graphs and plots effectively
Analysis of variance
Interpret statistical data to identify trends and deviations
www.globalcompliancepanel.com
All rights are reserved (c) GlobalCompliancePanel.

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USA Seminar 2012 at Washington
What you get:
Pricing List:
1. Learning Objectives
2. Participation certificates
1. Price for One Delegate pass
3. Interactive sessions with the US expert
$1895
4. Post event email assistance to your queries.
(Between March 23th to April 25th)
5. Special price on future purchase of web based trainings.
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6. Special price on future consulting or expertise services.
2. Early bird price for one Delegate
7. Special price on future seminars by GlobalCompliancePanel.
pass $1695
8. Seminar Kit - includes presentation handout, ID card, brochure, trainings catalog,
(Between February 16th to March 22th)
notepad and pen.
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9. Networking with industry's top notch professionals
3. For discounts on multiple
registrations, contact customer
care at 1800 447 9407
Companies that will benefit:
Medical Devices
Diagnostic
Professionals who will benefit:
Pharmaceutical
Development Scientists
Biologics
Analytical Method Development
QA/QC Personnel.
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
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Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,
6552 Palisades Dr. Centreville, VA 20121
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Kindly get in touch with us for
Fax: 302 288 6884
any help or information.
Email: support@globalcompliancepanel.com
GlobalCompliancePanel
Look forward to meeting you
NetZealous
at the seminar
1000 N West Street,
Team GlobalCompliancePanel
Suite 1200, Wilmington,
DE 19801..
www.globalcompliancepanel.com
All rights are reserved (c) GlobalCompliancePanel.

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