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When: Aug 19, 2018 4pm in Revere, MA

Examination of Laboratory, Medical and Device issues including Performance, Risk and Validation following Regulatory and ICH Statistical Guidelines (NTZ)

Examination of Laboratory, Medical and Device issues including Performance, Risk and Validation following Regulatory and ICH Statistical Guidelines *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are utilized, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how these guidelines are applied in practice.   Areas Covered in the Session: Upon completing this course participants should be able to: Evaluate linear quantitative measurement procedures and sources of error. Distinguish the difference between confidence and tolerance intervals Evaluate the appropriateness of the effect of sample size in given procedures. Evaluate laboratory/clinical quality control based on risk management Interpret statistical process control Distinguish between FDA requirements and ICH guidelines Who Will Benefit: This course is designed for people responsible for developing, maintaining and/or improving clinical and laboratory monitoring programs and interpreting the results from such. This includes individuals that have data monitoring responsibilities. The following personnel will benefit from the course: Quality Managers Quality Professionals Assay Development Scientists Research Scientists Data Analysts Laboratory Data Managers AGENDA Day 1 Schedule Registration Process: 8:30 AM - 9AM Session Start Time: 9AM Lecture 1: Overview of ICH Methodology Lecture 2: Introduction to the simple regression model Interpreting the slope and intercept in validation procedures Residual analysis and error detection Stability and Potency issues Lecture 3: Outlier strategies using the linear model in calibration methods Imputation techniques for missing data Outlier strategies for non normal or ranked data Consequences of outlier elimination/substitution Sample size and analysis issues Lecture 4: Confidence and tolerance bounds on risk models Parametric and non parametric (non normal data) procedures Exact computational techniques Day 2 Schedule Lecture 1: Discussion of risk management in general Traditional risk management strategies in clinical settings Predictive models in risk assessment Discussion of the Design Space Risk Management in pre-analytical phase of laboratory testing Lecture 2: Introduction to validation of models in hazard assessment and risk management Demonstration of laboratory Validation procedures Bivariate models and confusion matrices and derived statistics ROC plot Lecture 3: Statistical process laboratory control and capability Normal and non normal data procedures Evolutionary Operations Process Lecture 4: Confidence and tolerance bounds on limits of risk SPEAKER Alfred A. Bartolucci Dr. Al Bartolucci is Emeritus Professor of Biostatistics at the University of Alabama where he also serves as a Senior Scientist at the Center for Metabolic Bone Diseases, AIDS Research Center and Cancer Center. He previously served as Chairman of the Department from 1984 through 1997. He has also taught Statistical Software courses involving Data Exploration, ANOVA/Regression and Design of Experiments. His teaching experience includes areas such as, Clinical Trials, Survival Analysis, Multivariate Analysis, Regression Techniques and Environmental/Industrial Hygiene Sampling and Analysis, Bayesian Statistics, and Longitudinal Data Analysis. Dr. Bartolucci received his PhD in Statistics from the State University of New York at Buffalo and his MA in Mathematics from Catholic University, Washington DC, and his BA in Mathematics from Holy Cross. Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:- Multiple participant discounts- Price quotations or visa invitation letters- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)- Event sponsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------This event is brought to you by:Netzealous LLC - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------MYL180602CEV MYL180615CHK MYL180712UPR

When: Aug 20, 2018 8:30AM in Revere, MA

Trio Parada Dura

When: Aug 24, 2018 9pm in Revere, MA

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About Revere, MA
Revere Massachusetts is home of the famous Revere Beach which has been a destination location for many generations. The amusements are gone but the beauty of the beach is still available to everyone who visits.

Revere is a highly developed residential suburb located about 5 miles from downtown Boston. Almost 900 acres of Revere is open water and wetlands and the rest is used for residential-commercial and transportation purposes.

Revere is within a short distance to all major urban amenities including museum and medical facilities as well as theaters and institutions of higher learning and is even close by Logan International Airport. The city is convenient to Routes 1 as well as Route 93 and Route 128. With three public MBTA transportation systems-you can get anywhere in the world from Revere!

Revere Beach was the first public beach in the United States and is host to Wonderland Dog Racing Track and Suffolk Downs Horse Racing Track. Revere's multi-cultural and diverse population enjoys its residential neighborhoods and takes pride in its recently developed and improved extensive system of parks.