Boston Professional Events List

Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

May 04, 2017 - 08:30 AM - May 05, 04:30 PM
Embassy Suites By Hilton Boston,

ZIP: 02128
Phone: 1 929 900 1853

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.

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:

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
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
- For event ticket, contact +1 929 900 1853
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
This Event Listing is Promoted  by
New York Media Technologies LLC in association
with GlobalCompliancePanel.


Day 1 Schedule

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 Details

Al Bartolucci, Ph.D.


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.

Event Categories
Keywords: fun, analysis, applications, Clinical , design , developing, development , Fun , graphical , lear


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