Statistical Analysis for Product Development: 2-day In-person Seminar
Steven Walfish, President of Statistical Outsourcing Services
San Francisco, CA
| Thursday, December 11, 2014 | Friday, December 12, 2014
This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible.
This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development.
- Learn the technical details and rationale for selecting and analyzing well designed statistically based experiments.
- Develop the confidence to design and execute experiments that maximizes information in your day-to-day activities.
- Participate in discussions with other course attendees to increase your confidence and proficiency in statistical hypothesis testing.
- Determine the most robust settings in your process to minimize the different sources of variability.
Who should Attend:
This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Development scientists
- Analytical method development, and QA/ QC personnel.
|Day One (8:30 AM – 4:00 PM)
||Day Two (8:30 AM – 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction to Statistical Hypothesis Testing (2 Hours)
Working with Confidence (1.5 Hours)
- Null hypothesis versus the alternative
- Different errors that can be made in doing statistical tests
- When do we use the Z-test and when do we use the t-test
- Testing variances
Overview of Analysis of Variance and Variance Components (3.5 hrs)
- Confidence Intervals
- Tolerance Intervals
- Sample Size
- Fixed versus Random Effects
- What does a p-value mean and how do I interpret them?
- Understanding an ANOVA table
- How do I use ANOVA to calculate variance?
- Screening Out Noise (2 Hours)
Design Control (2 Hours)
- Screening experiments
- Resolution of a design
- What is an interaction?
- Building an appropriate model
Regression Analysis (2 Hours)
Analytical Method Validation (1.5 hours)
- Design Verification
- Design Validation
- Accuracy and Linearity
Meet Your Instructor
President of Statistical Outsourcing Services
Steven Walfish , is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated 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 was Manager of Non-Clinical Statistics at Chiron Diagnostics.
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.
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Palo Alto, CA 94303
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San Francisco, CA (Venue to be announced shortly)
December 11-12, 2014
Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
- RABQSA CMS Auditor, Diagnostica Stago, Inc
ComplianceOnline always has Conferences available to keep me informed on changes to regulatory guidance. Steven is great presenter. He engage the group to discuss the topics in the presentation.
- Sr. Mfg Manager, FibroGen Inc.
The program was well organized and coordinated. I like the ICH guidelines, DOE, specifications.
- QA Associate, Dr Reddy's Laboratories
This seminar is good for statisticians. ComplianceOnline is doing well with organizing seminars and webinars.
- Associate Director, Dr Reddy's Laboratories
Great examples and stories. Steven kept things interesting and relevant. I like the sessions on Q7 - GMP for API and trending of process parameters / control.
- Project Manager, Bayer HealthCare, LLC
I like the concept and use of DOE and specific settings. Good topics covered in this seminar with combined thought process. It was a well organized event by ComplianceOnline.
- Head - Development Quality Assurance, Dr Reddy's Laboratories
It was good to see common approaches for specification setting. Good practical feedback as to standard practices and regulatory expectations.
- Senior Engineer II, Shire
The seminar was very good and useful to my area. I like the areas covered on statistical analysis for method validation - Because I am doing lots of validation, method transfer etc. ComplianceOnline is a great tool for quality organizations.
- Associate Director, Pfizer
I like the Stability statistics session. Very knowledgeable presenter who was willing to listen to attendees expertise.
- Senior Stability Scientist, Noven Pharmaceuticals
The training covered a large amount of data but moved at a good pace with lots of examples. The venue was very good and seminar was well organized by ComplianceOnline.
Good introduction to all areas of ICH and the statistics used with programmatic to implement them at your company. The presenter was very knowledgeable.
- Global Head Stability, GlaxoSmithKline Consumer Health R&D
The presentation and flow was well organized and related. I like the Tolerance Intervals since they relate to single point measurements.
- DPT Labs
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services
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