Laboratory, medical and device performance and validation following regulatory and ich statistical guidelines
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This document outlines a 2-day in-person seminar led by Dr. Al Bartolucci focusing on laboratory, medical, and device performance validation according to regulatory and ICH statistical guidelines, taking place in Miami, FL on July 27th and 28th, 2017. The seminar will cover various statistical concepts and techniques relevant to quality management and risk assessment, aimed at professionals such as quality managers and data analysts. Registration is priced at $1,295 per delegate with early bird discounts available, and includes access to networking opportunities and a seminar kit.
Laboratory, medical and device performance and validation following regulatory and ich statistical guidelines
- 1. 2-day In-person Seminar: Knowledge, a Way Forward… Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines Miami, FL July 27th & 28th, 2017 8:30 AM to 4:30 PM Al Bartolucci, Ph.D. Price: $1,295.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Overview : Global CompliancePanel 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. 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. $6,475.00 Price: $3,885.00 You Save: $2,590.0 (40%)* Register for 5 attendees
- 2. Global CompliancePanel Agenda: Day One Day Two 2-day In-person Seminar: Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines Lecture 1: Overview of ICH Methodology Learning Objectives: 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: Quality Managers Quality Professionals Assay Development Scientists Research Scientists Data Analysts Laboratory Data Managers 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 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
- 3. Global CompliancePanel www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 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. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 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 +1-800-447-9407 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 +1-800-447-9407 for the wire transfer information 3 4 2-day In-person Seminar: Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines