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:
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:
AGENDA
Day 1 Schedule
Registration Process: 8:30 AM - 9:00 AM
Session Start Time: 9:00 AM
Lecture 1:
Overview of ICH Methodology
Lecture 2:
Introduction to the simple regression model
Lecture 3:
Outlier strategies using the linear model in calibration methods
Lecture 4:
Confidence and tolerance bounds on risk models
Day 2 Schedule
Lecture 1:
Discussion of risk management in general
Lecture 2:
Introduction to validation of models in hazard assessment and risk management
Lecture 3:
Statistical process laboratory control and capability
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(at)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 sponsorship
NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
-----------------------------------------------------------------
This event is brought to you by:
NETZEALOUS LLC - NewYorkEventsList
-----------------------------------------------------------------
VIO180710CRE