ComplianceOnline

Many Quality Engineers join the workforce with technical understanding of the products without the statistical understanding of product variability. The FDA's findings of deficiencies concerning sample size, gage studies, statistical process control and other statistical issue indicate the agencies expect definitive evidence that statistics are properly applied. Case studies and example from FDA 483 findings will be presented.

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations?

In this two day workshop conference you will learn the different statistical tools necessary to comply with global agencies expectations. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices can help or hurt your liability that arises from nonconformance with regulators and Auditors.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should:

  • Understand measures of location and dispersion of their data
  • Utilize hypothesis testing and confidence intervals to explain statistical differences.
  • Understand Analysis of Variance techniques.
  • Perform regression analysis for stability studies.
  • Design and analyze experiments using DOE
  • Understand different types of measurement system analysis studies and when to use them.
  • Problem solving methods to help you assess which is best for your situation
  • Develop successful implementation plans
  • Perform risk assessments effectively

Who will Benefit:

This course is designed for quality professionals tasked with developing, maintaining and/or improving products and/or processes. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance. Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 9:00 am)
  • Lecture 1: Data and Graphical Analysis
  • Lecture 2: Hypothesis Testing
  • Lecture 3: Confidence Testing
  • Lecture 4: ANOVA
Day 02(8:30 AM - 4:00 PM)
  • Lecture 5: Regression
  • Lecture 6: DOE
  • Lecture 7: MSA
  • Lecture 8: Sample Size
  • Lecture 9: Capability Analysis
  • Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$2,299.00

Seminar One Registration

October 16-17, 2018, Foster City, CA




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


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

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ +1-888-717-2436 or email us @ customercare@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 $300 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 ($300) 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.

Conference photograph / video:
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 ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

Courtyard by Marriott San Mateo Foster City
550 Shell Blvd
Foster City, CA 94404, USA
Tel: +1 650-377-0600

October 16-17, 2018

How to Reach

General Driving Directions:

Driving Directions from San Francisco International Airport – SFO - 9.5 miles SE:
  • Take Hwy 101 South to 92 East Exit Foster City Blvd.
  • Turn right at first light, then turn left onto Shell Blvd.
  • Make a U-turn at the first turn-out on the left, turn right into parking lot.
Driving Directions from Oakland International Airport – OAK - 23 miles SW:
  • Take South 880 to 92 West Ramp to San Mateo Bridge Exit Foster City Blvd.
  • Bear right at Chess Drive, bear right and head towards Foster City Blvd., bear right at Metro Center Blvd, then turn left on Shell Boulevard.

Other Transportation:

Bus Station
  • Greyhound Bus Station San Francisco 22.7 miles N

Subway Station
  • BART Millbrae Station 6 miles N
  • Hillsdale Caltrain Station 2 miles SW

Train Station
  • Hillsdale Caltrain 3 miles SW

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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