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					                                                                                                                    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 © GlobalCompliancePanel.
          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
                                                                 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 © GlobalCompliancePanel.
                                                                      USA Seminar 2012 at Washington

What you get:
1. Learning Objectives
                                                                                          Pricing List:
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.                               -----------------------------------------
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.                                                                      -----------------------------------------
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
v   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
    Email: support@globalcompliancepanel.com
                                                                                           any help or information.
    GlobalCompliancePanel                                                               Look forward to meeting you
    NetZealous                                                                                  at the seminar
    1000 N West Street,                                                                 Team GlobalCompliancePanel
    Suite 1200, Wilmington,
    DE 19801..




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