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

By: Steven Walfish, President of Statistical Outsourcing Services
Coming soon.. Please contact customer care for new schedule
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.

We need the below information to serve you better

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)
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?
Day Two (8:30 AM – 4:00 PM)
  • Screening experiments
  • Resolution of a design
  • What is an interaction?
  • Building an appropriate model
    • Design Control (2 Hours)
      • Design Verification
      • Design Validation
    • Regression Analysis (2 Hours)
      • Product Stability
    • Analytical Method Validation (1.5 hours)
      • Accuracy and Linearity
      • Precision

Meet Your Instructor

Steven Walfish
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.
Location :
Grand Hyatt San Francisco
345 Stockton Street,
San Francisco, California, USA, 94108
December 11-12, 2014

Special Offer for the attendees of this seminar:

Rooms available at 15% discount and with free internet.

Use the code "CR88975" at the time of booking to avail of this offer.

Please note: Hotel rooms are limited and based on availability.

How to Reach

General Driving Directions:

From San Francisco International Airport: 14 miles
  • Take 101 North toward the San Francisco and Bay Bridge.(Cambridge)
  • Exit 280 North toward "Port of SF/280 North". Stay in left lane and 280 becomes King Street.
  • At 2nd light, turn left onto 3rd St and go 8 blocks to Market St.
  • Cross over Market St. (which becomes Kearny St.) and continue 2 blocks.
  • Turn left on Sutter St. Go 2 blocks to Stockton and the hotel is located on the left corner.

From Oakland Airport: 20 miles
  • Take 880 North toward San Francisco and cross over on the Bay Bridge.
  • Take the Fremont St. Exit (on right) & proceed 1/2-block on Fremont St.
  • Turn left onto Howard St & Turn right onto 3rd St.
  • Cross Market St. (Street changes to Kearny).
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left.

From San Jose International Airport: 46 miles
  • Take 101 North toward San Francisco for approximately 43 miles
  • Take I-80 East toward Bay Bridge/Oakland.
  • Exit at Fourth Street toward Embarcadero.
  • Make a slight left onto Bryant Street.
  • Then a left onto Third Street & Third Street will become Kearny Street.
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left to reach the Hotel.

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. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

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
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "Statistical Analysis for Product Development: 2-day In-person Seminar"
Click here to Download Registration Form
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

Terms & Conditions to register for the Seminar/Conference/Event

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 @ +1-888-771-6965 or email us @


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 GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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.

Conference photograph / video:

By registering and attending GRC Seminars 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 GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.


Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
- Sr. Mfg Manager, FibroGen Inc.

This seminar is good for statisticians. GRC Seminars is doing well with organizing seminars and webinars.
- QA Associate, Dr Reddy's Laboratories

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 GRC Seminars.
- Head - Development Quality Assurance, Dr Reddy's Laboratories

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. GRC Seminars is a great tool for quality organizations.
- Associate Director, Pfizer

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 GRC Seminars.
- Novartis

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

The program was well organized and coordinated. I like the ICH guidelines, DOE, specifications.
- QA Associate, 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

It was good to see common approaches for specification setting. Good practical feedback as to standard practices and regulatory expectations.
- Senior Engineer II, Shire

I like the Stability statistics session. Very knowledgeable presenter who was willing to listen to attendees expertise.
- Senior Stability Scientist, Noven Pharmaceuticals

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

Media Partners

If you wish to partner with us for this event please contact us: or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


If you wish to sponsor this event please contact Ben Hobbs: or call us: (650) 620-2941

Local Attractions

Think Escape Party Bus
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity