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

By:
Steven Walfish, President of Statistical Outsourcing Services
Location :-
San Francisco, CA
| Thursday, December 11, 2014 | Friday, December 12, 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

$1,299.00

Seminar One Registration

December 11-12, 2014, San Francisco, CA
(Early bird price valid till October 25, 2014)
Actual Price: $1,699

$6,099.00
$7,794.00
You Save: $1,695.00 (21%)*

Special Group Discount Register for Six attendees

December 11-12, 2014, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left


Register Now and Save $400 (Offer Extended)
For Registrations till October 25, 2014 $1,299
Actual Price $1,699
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

Register by Wire Transfer




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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 2 days before 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 before 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 5 working days before the seminar date. Please bring the pass to the venue of the event.

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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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