Statistics for the Non-Statistician

About GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. 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. P ro fess iona l s who unde rgo t ra in ings f rom GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowNet Zealouswww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar:Statistics for the Non-Statistician By: President, Statistical Outsourcing ServicesSteven Wal?sh,Location : Zürich, Switzerland | March 3-4, 2014GlobalCompliancePanelCourse "Statistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recerti?cation upon full completion. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Steven Wal?sh, President, Statistical Outsourcing Services2-day In-person Seminar 2014Mr. Steven Walfish brings is the founder and President of Statistical Outsourcing Services. He brings nearly 20 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.Day One - March 3, 2014 Day Two - March 4, 2014Course Outline:GlobalCompliancePanelOverview:Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, Lecture 1: Introduction and Basic Overview of Common Statistical ToolsExercise: Identify Participants' Statistical Experience and Course Goals? Types of Data? Continuous versus discrete? Descriptive versus inferential? Data Presentation and Graphics? Normal Distribution? Introduction to Hypothesis Testing? P-value? z-test? t-test? Chi-square? F-test? Discuss applicable software packages for use:? Microsoft Excel - SAS? Mini-tab - JMPLecture 2: Apply Statistics to Speci?cation Setting? Setting appropriate product speci?cations ? Determine FDA requirements for OOS results? Determine how to best investigate OOS results? Introduction to Interval Estimation? Con?dence Interval? Tolerance Interval? Outlier AnalysisExercise: Setting Statistical Based Speci?cationsLecture 3: Regression analysis and variance components? Correlation? Linear models? New Patient Rights? Residual analysis ? Lack of ?t ? 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 varianceExercise: Mock Experimental DesignLecture 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? Quantify validation characteristics:? linearity - range? accuracy - limit of detection (LOD)? precision - limit of quantitation (LOQ)? Regression analysis and variance components? Analysis of Stability data.Exercise: Analysis of a Method Validation Study Including Protocol Development Lecture 6: Trending Analysis? De?ne Statistical Process Control (SPC) ? Determine how SPC can be applied to and help your process? Identify the bene?ts of using SPC? Trend Analysis? Comply with FDA Requirements for Process Analytical Technology (PAT)? De?ne 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 TechnologyExercise: Review and Critique a Sample SPC Control Chart Lecture 7: Design a Statistically Sound Sampling Plan? De?ne different types of sampling? random? strati?ed? composite? Create and justify your sampling plan? Account for sampling and measurement error? Determine the relationship between sample size, statistical precision, and statistical powerExercise: Create a Mock Sampling Plan 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 deviationsExercise: Apply Learned Statistical Techniques to Real-World DataDiscussion: Wrap-up Question and Answer Sessionresulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data setswww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar 2014Register now and save . (Early Bird)$200Until February 21, Early Bird Price: $1,595.00From February 22 to March 01, Regular Price: $1,795.00March 3-4, 2014 | Zürich, Switzerland**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.Price for One Delegate pass Price: $1,595.00Pricing list:1. Learning Objectives2. Participation certificates3. Interactive sessions with the US expert4. 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 professionalsWhat you get? Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link? Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA? PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884 ? Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer informationPayment Options:Who Will Benefit:Contact Information: Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comNetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanelGlobalCompliancePanelThis course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies:? Medical Device? Diagnostic? Supervisors? Pharmaceutical? Biologics ?eldsThe employees who will bene?t include: ? Development Scientists? Analytical Method Development? QA/ QC personnelwww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Registration :FormPlease use this form to register online, using your American Express, Visa or MasterCard.To get discounts on group attendance, please call us on +1-800-447-9407Call us on or fax your PO to 302 288 6884+1-800-447-9407Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include +1-800-447-9407 support@globalcompliancepanel.comattendee and payment details in it and fax it to 302 288 6884Terms and ConditionsYour registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clari?cations or doubts on this issue.Cancellations and SubstitutionsIf you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period.A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this.You are allowed to make substitutions at any time till the start of the event. 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Bill me/my company $ ............................................................Purchase order # ........................................................................(Payment is required by the date of the conference.)Please ?ll this form with attendee details and payment details and fax it to 302 288 6884NetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAToll free (US): +1-800-447-9407 / Fax (US): 302 288 68842-day In-person Seminar 2014GlobalCompliancePanel