Statistical Analysis for Product Development: 2-day In-person Seminar
Steven Walfish, President of Statistical Outsourcing Services
Thursday, April 24, 2014 | Friday, April 25, 2014
Thursday, June 26, 2014 | Friday, June 27, 2014
|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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Madison, WI(Venue to be announced shortly)
April 24-25, 2014
Philadelphia, PA (Venue to be announced shortly)
June 26-27, 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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Madison, WI, Local Attractions
Philadelphia, PA, Local Attractions
Henry Vilas Zoo
Henry Vilas Zoo is a 28-acre (11 ha) public zoo in Madison, Wisconsin, United States. Owned by the city of Madison, the zoo charges no admission or parking fees. A wide variety of animals from around the world are on display. The Henry Vilas Zoo also runs an educational program they call Zoo School, fun fund raising events, and some onsite rides, including a carousel. It receives over 500,000 visitors annually.
Monona Terrace Community and Convention Center
Fans of Frank Lloyd Wright will want to see the building he proposed but never built - the Monona Terrace Community and Convention Center. This visually stunning building is on the waterfront and has a curving glass façade. Tours of the building are available and provide an insight into Frank Lloyd Wright's genius.
Wisconsin Veterans Museum
The Wisconsin Veterans Museum in Madison showcases the history of wars the US has been involved in. Military paraphernalia is on display as are informative dioramas. The museum has won numerous awards for its work over the years. The Wisconsin Veterans Museum also operates a research center where items related to the various conflicts can be accessed.
State Street is a lively shopping and dining hotspot in downtown Madison with trendy shops, street musicians, art galleries, restaurants, bars and sidewalk cafes. Enjoy Madison's best people watching on this six-block pedestrian mall connecting UW Madison's campus to the State Capitol building. For a taste of art and culture, State Street is also home to the Overture Center for the Arts, the Madison Museum of Contemporary Art, and the historic Orpheum Theatre.
University of Wisconsin
The University of Wisconsin-Madison enjoys a long history of academic, artistic and athletic achievement dating back to its founding in 1848. The beautiful and historic 933-acre campus in Madison boasts four National Historic Landmarks and famous attractions, such as the Memorial Union on the shores of Lake Mendota - where people meet, eat, hear music and relax in the iconic Terrace chairs.
Lake Mendota is the northernmost and largest of the four lakes in Madison, Wisconsin. It is ideal for boating in the summer, and ice skating or ice fishing in winter.
Ice Age National Scenic Trail
This hiking trail passes some fascinating geological formations formed by the recession of giant glaciers during the Ice Age, between 70,000 to 10,000 years ago. It will be of interest to more than just those fascinated by the powerful effects of glaciation. Walkers, hikers, and bikers will also be interested because the trail when finally completed will be 1,000 miles long and will stretch from Potawatomi State Park to St Croix Dalles.
Olbrich Botanical Gardens
One of Madison's most popular attractions, this oasis of green includes a sunken garden, perennial garden, rose garden, rock garden, herb garden, wildflower garden and a tropical conservatory. The Bolz Conservatory, a sunny 50-foot-high glass pyramid, houses a diverse collection of tropical plants, a rushing waterfall, free-flying birds, and blooming orchids year-round. The Botanical Center is complete with a gift shop, horticultural library, and meeting rooms.
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
The Barnes Foundation
The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.
The Rocky Statue
One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.