• Introduction and basic overview of Common Statistical Tools
• Fundamental Tools in Statistics
• Statistical Process Control - Pareto chart
  • Control Charts
  • Trending analysis
  • Control chart diagnostics
  • Design a statistically sound sampling Plan
• Outliers
• Applying statistics to specification Setting
• T-test (one-sample, two-sample and paired)
• Tolerance intervals and confidence intervals
• Capability analysis - Cp, Cpk, Pp and Ppk
• Implementing Design of Experiments (DOE)
• Regression analysis
• Interpreting a normal probability plot
• Comparing confidence interval of parameters to p-value
• Method Validation – ICH Q2R1 – Accuracy, Linearity, and Precision
• Variance components
• Statistics  for Annual Product Review (APR) and how to present data

Participants will be divided into groups of 4 to work on each case study and they will lead the discussion on the “report out” for each case study.

• CASE STUDY (1): Interpreting data and calculating summary statistics
• CASE STUDY (2): Setting Specifications and what would be the best approach?
• CASE STUDY (3): “Bake a Cake” - Using DOE, make the best cake using a three factor model
• CASE STUDY (4): Using Excel to do Regression - Developing a simple linear model and checking for residual patterns.
• CASE STUDY (5): Determining the accuracy and linearity of the assay by providing a data set.
• CASE STUDY (5): Reviewing Control charts - Setting up a control chart from a data set and determining if the process is in control.
• CASE STUDY (6): Developing Sampling Plans

This two-day comprehensive hands-on workshop training offers a detailed introduction to the fundamental principles and concepts in statistical analysis used in pharmaceutical, biotech, and allied industries. The applied sessions are aimed at all life sciences scientific professionals involved in designing experiments and analyzing data.

The first part of the course covers classical and more recent techniques used to describe data with numerical and graphical tools. The various uses of these methods like statistical process control, outlier detection, and applying statistics in setting up specification are presented.

Using real-world, examples, the second part this course addresses, the principles underlying statistical testing and decision-making in the presence of uncertainty.

After completing this course the attendees will:

• learn the statistical concepts underpinning Statistical Process Control
• understand the effects of variation on processes and be able to use that understanding to make sound decisions
• be able to set up a control chart from a data set and determine if the process is in control
• be able to develop sampling plans
• be able to determine the accuracy and linearity of the assay
• develop a simple linear model and be able to check for residual patterns
• Much much more

The hands-on case study workshops will provide the necessary foundations for more specialized expertise in any area of statistical data analysis as it applies to life sciences. The selected topics will cover basic assumptions of most statistical methods and/or have been demonstrated in research to be necessary components of one's general understanding of the "quantitative nature" of reality.

Participants will be required to bring their own laptop computer on which to run the analysis exercises.

Mr. Steven Walfish President Statistical Outsourcing Services

Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to variety of industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.

Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Mr. Walfish concentrates his efforts on the medical device, pharmaceutical and biotechnology industries.

Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

Day 1 - Tuesday February 2, 2010
08:00 AM	Registration and Continental Breakfast
08:30 AM	Introduction and Basic Overview of Common Statistical Tools
	Discrete versus Continuous data Summarizing data Location and spread Graphs and tables Data distributions Normal Lognormal Binomial Poisson Chi-Square Outliers CASE STUDY: Interpreting data. Is data normal? Are there outliers? Calculating summary statistics
	Applying Statistics to Specification Setting
	Defining a specification Hypothesis testing t-test (one-sample, two-sample and paired) Tolerance intervals and confidence intervals Capability analysis Cp, Cpk, Pp and Ppk CASE STUDY: Setting Specifications Given a set of data, determine the best set of specifications What is the probability of meeting the specification? What is the best approach?
	Implementing Design of Experiments (DOE)
	DOE versus one factor at a time. Design resolution Screening Designs Factorial Designs Response Surface Designs ANOVA CASE STUDY: “Bake a Cake”                     Using DOE, students need to make the best cake using a three factor model.
	Regression Analysis
	Linear models Model assumption and hazards Model diagnostics Residuals Confidence intervals on slope and intercept CASE STUDY: Using Excel to do Regression: Develop a simple linear model Check for residual patterns. Interpret a normal probability plot Compare confidence interval of parameters to p-value.
4:30 PM	Questions & Answers
4:45 PM	Conclusion of Day One
Day 2 Wednesday February 3, 2010
08:00 AM	Continental Breakfast
08:30 AM	Method Validation – ICH Q2R1
	Accuracy/Linearity Precision Variance components CASE STUDY: Linearity/Accuracy of an Assay Students will be given a data set to determine the accuracy and linearity of the assay.
	Statistical Process Control
	Pareto chart Control Charts Trending analysis Control chart diagnostics CASE STUDY: Reviewing Control charts Set up a control chart from a data set Determine if the process is in control
	Design a Statistically Sound Sampling Plan
	Types of sampling plans Power of a sample Sampling error Continuous sampling size calculation Attribute sampling CASE STUDY: Developing Sampling Plans: For a given risk level, how large does the sample need to be? For a given sample size, what is the risk of making Type I and Type II errors? Reading the ANSI/ASQ Z1.4 Relate sample size back to specification setting.
	Annual Product Review
	Statistics for APR How to present data
3:45 PM	Questions & Answers
4:00 PM	Conclusion of the course

This applied training is specially designed for managers, supervisors, analysts, and associates in the Pharmaceutical, Biotechnology, Medical Device, and allied industries with daily responsibilities in the following areas:

• Process Development & Operation
• Quality Assurance
• Quality Control
• Manufacturing
• Statistical Analysis
• Validation
• Data Interpretation
• Change Control
• Analytical Laboratories
• Annual Product Review (APR)
• Stability
• Training
• Consultants  
• Contract Services

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Doubletree Hotel, Jersey City Doubletree Hotel-Jersey City 455 Washington Boulevard Jersey City, NJ 07310 Hotel Front Desk: 1-201-499-2400 Hotel Fax: 1-201-499-2406
For more information, please call us at 416-410-7402 or enquiry@ipacanada.com