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2-day In-person Seminar

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

May 4th & 5th, 2017

Time: 8:30 AM to 4:30 PM

Boston, MA

Venue: Embassy Suites Boston Logan Airport


Director : Alfred Bartolucci

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,295.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $3,885.00
      $6,475.00 You Save: $2,590.00 (40%)*
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    • Until March 31, Early Bird Price: $1,295.00 From April 01 to May 02, Regular Price: $1,495.00
Course "Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

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

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Phone: 1800 447 9407

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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.

Location: Boston, MA Hotel: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

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