EXAMINATION OF LABORATORY, MEDICAL AND DEVICE ISSUES INCLUDING
PERFORMANCE, RISK AND VALIDATION FOLLOWING REGULATORY AND ICH
STATISTICAL GUIDELINESABOUT
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 - 9:00 AM
-------------------------
Session Start Time: 9:00 AM
-------------------------
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(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.
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Four Points by Sheraton Boston Logan Airport Revere, MA
407 Squire Rd, Revere,, Boston, 2151, MA, United States