Seminar on Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines training seminars presented by Global Compliance Panel register now on FindaSeminar.com

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

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By:

Global Compliance Panel   

For:

Quality Managers, Quality Professionals, Assay Development Scientists, Research Scientists, Data Analysts, Laboratory Data Managers

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


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

Overview:
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


Agenda:
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:
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.

Seminar Summary:

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. (see full course description)

print this agenda print agenda for the Seminar on Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines training seminar

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