statistics for the non statistician seminar brochure

8/2/2019 Statistics for the Non Statistician Seminar Brochure

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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 ITControl & 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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Steven WalfishPresident, Statistical Outsourcing Services


bout Speaker:

teven Walfish is the President of Statistical Outsourcing Services, a consulting company that

rovides statistical analysis and training to FDA regulated industries.

rior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager

iostatistics, 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

dustry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics.

r. Walfish brings over 20 years of industrial expertise in the development and application of

atistical methods for solving complex business issues including data collection, analysis and

eporting.

May 24th and 25th, 2012 at Washington

Will be announced soon

Date and Venue:

ast Seminars


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eminar Content: Conference timings: 9 AM PDT to 5 PM PDT

ay 1 - 5th April 2012 Day 2 - 6th April 2012


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 variancecomponents

„ 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 identifyrelated 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


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ow to Register:

Register online. Use your American Express, Visa or MasterCard

For group discount of more than 5 attendees call 800-447-9407

Call +1 - 800-447-9407 or Fax your PO: 302-288-6884

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 forany help or information.

Look forward to meeting youat the seminar

Team GlobalCompliancePanel


. Learning Objectives

. Participation certificates

. Interactive sessions with the US expert

. Post event email assistance to your queries.

. Special price on future purchase of web based trainings.

. Special price on future consulting or expertise services.

. Special price on future seminars by GlobalCompliancePanel.

Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,

notepad and pen.

. 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:

statistics for the non statistician seminar brochure

Documents