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: firstname.lastname@example.org 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.. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.