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Statistical Analysis for Product Development: 2-day In-person Seminar

By:
Steven Walfish, President of Statistical Outsourcing Services
Location 1:-
Hyatt Place Madison/Downtown, WI

Thursday, April 24, 2014 | Friday, April 25, 2014
Location 2:-
Courtyard Philadelphia Downtown, PA

Thursday, June 26, 2014 | Friday, June 27, 2014

Course "Statistical Analysis for Product Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

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.


Learning Objectives:

  • 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
  • Engineers
  • Analytical method development, and QA/ QC personnel.




Course Outline:

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

  1. Introduction to Statistical Hypothesis Testing (2 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
  2. Working with Confidence (1.5 Hours)
    • Confidence Intervals
    • Tolerance Intervals
    • Sample Size
  3. Overview of Analysis of Variance and Variance Components (3.5 hrs)
    • 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?
  1. Screening Out Noise (2 Hours)
    • Screening experiments
    • Resolution of a design
    • What is an interaction?
    • Building an appropriate model
  2. Design Control (2 Hours)
    • Design Verification
    • Design Validation
  3. Regression Analysis (2 Hours)
    • Product Stability
  4. Analytical Method Validation (1.5 hours)
    • Accuracy and Linearity
    • Precision





Meet Your Instructor

Steven Walfish
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.





Register Online

$1,599.00

Seminar One Registration

April 24-25, 2014, Madison, WI

$7,299.00
$9,594.00
You Save: $2,295.00(23%)*

Special Group Discount Register for Six attendees

April 24-25, 2014, Madison, WI
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left

$1,399.00

Seminar One Registration

June 26-27, 2014, Philadelphia, PA
(Early bird price valid till April 25, 2014)
Actual Price: $1,599

$6,499.00
$8,394.00
You Save: $1,895.00(22%)*

Special Group Discount Register for Six attendees

June 26-27, 2014, Philadelphia, PA
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left


Register Now and Save $200 (Early Bird Price)
For Registrations till April 25, 2014 $1,399
Actual Price $1,599
Early Bird Seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436

Register by P.O. / Check


Yes, I want to attend "Statistical Analysis for Product Development: 2-day In-person Seminar"

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Venue

Location 1:

Special Offer for the attendees of this seminar:

Rooms available at only $139 per night.

Call 1-888-492-8847 and identify yourself as part of the ComplianceOnline Group

Or Log on to avail this offer.

Please note: Hotel rooms are limited and based on availability




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How to Reach

General Driving Directions:

Driving Directions from Dane County Regional Airport (MSN):
  • Leaving the airport, travel north on International Lane and follow toward Terminal.
  • Turn left on Packers Avenue/WI-113 South.
  • Continue to follow WI-113 South.
  • Turn left on North 1st Street (WI-113 South).
  • Turn right onto East Washington Avenue/US-151 South.
  • Continue to follow East Washington Avenue and turn right onto North Webster Street.
  • Turn left onto E. Dayton Street.
  • Turn left onto North Fairchild Street.
  • Turn right onto West Washington Avenue. The Hyatt Place Madison/Downtown is located on the left-hand side

Driving Directions from General Mitchell International – Milwaukee Airport (MKE):
  • Leaving the airport, follow signs toward I-94/I-90 West to Madison.
  • Keep left to take WI-30 West toward Madison.
  • Merge onto East Washington Avenue toward State Capitol.
  • Turn right onto North Webster Street.
  • Turn left onto East Dayton Street. Turn left onto North Fairchild Street.
  • Turn right onto West Washington Avenue. The Hyatt Place Madison/Downtown is located on the left-hand side.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.



Location 2:



View Larger Map


How to Reach

General Driving Directions:

Driving Directions from Philadelphia International Airport – PHL: 10 mile(s) SE
  • Take Interstate 95 North to Interstate 676 West
  • Exit at Broad Street (Route 611)
  • Stay in the left lane and take the first left turn onto Vine Street
  • Continue on Vine Street to 12th Street and turn right
  • Proceed to Market Street and turn right
  • Follow Market Street toward City Hall and the hotel will be on the right immediately after the first traffic light.

Other Transportation:

Bus Station
  • Greyhound Bus Lines: 0.3 mile(s) E

Subway Station
  • 13 St Station: 0.1 mile(s) SE
  • Blue Line: 0.1 mile(s) S

Train Station
  • Amtrak-PHL: 1.2 mile(s) W

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.





Testimonials

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.
- Novartis

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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  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

 





Madison, WI, Local Attractions

Philadelphia, PA, Local Attractions

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.




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.




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.




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.




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.




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.




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.




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 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.




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.”




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 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.




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.







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