Statistical Process and Quality Control


Date & Time:
12 Dec - 13 Oct 2019

Location:
San Diego, CA, USA

Download:
Seminar Brochure



REGISTRATION OPTIONS

1 Delegate
  • $1,500.00 $1,200.00
  • Register for 1 Attendees
  •       
Group of 3 Delegates
  • $4,500.00 $3,240.00
  • Register for 3 Attendees
  •       
Group of 5 Delegates
  • $7,500.00 $4,800.00
  • Register for 5 Attendees
  •       

This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and testing within the statistical framework.

Presented examples will include an emphasis on the manufacturing processes and quality assurance needs of personnel in the medical device and pharmaceutical industries.

Why You Should Attend:

All processes exhibit intrinsic variation. However, sometimes the variation is excessive and this hinders the ability to achieve reliable measurements and desired results. Statistical process control (SPC) and statistical quality control (SQC) allow us to control the functions of our processes (input) and the quality of our product (output) by providing tangible tools for monitoring and testing.

Process and quality control is important for a company’s reputation. A good system of processing and quality checks reduce costs associated with production waste and re-work due to defects, and allows a company to deliver products that are high in quality. Many industries are also required to have a good quality management system in place to achieve compliance with regulatory authorities.

This seminar will provide attendees with the statistical tools necessary to monitor processes and test the quality of manufactured product. Ms. Eisenbeisz will make use of Minitab software in her presentation.

Areas Covered in the Session:

  • FDA QSR, ISO 13485:2016, ISO 9001:2015 regulations and harmonization
  • Overview of statistical theory and nomenclature for processes and quality control
  • Variability and risk assessment in practice
  • Control before testing!
  • Which chart for which process?
  • Presentation of control charts for discrete and continuous data
  • Setting statistical specifications, control limits, and signals
  • Attribute and Variables sampling plans
  • C = 0/Zero acceptance sampling plans

Who Should Attend :

  • Quality Assurance Department Management and Staff
  • Quality Control Department Management and Staff
  • Research and Development Department Management and Staff
  • Manufacturing Department Management and Staff
  • Engineering Department Management and Staff
  • Operations Department Management and Staff
  • Production Department Management and Staff
  • Processing Facilities Management
  • Process Control Personnel

Elaine Eisenbeisz

Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.

DAY 1 : (8.30 AM – 4.30 PM)

It’s a System! Elements of Quality Management

  • Deming 14 points for total quality management
  • Dr. Ishikawa, seven quality control tools (7-QC) and supplementals (7-SUPP)
  • Pareto principle (80/20 rule)
  • Shewhart (Plan, Do, Study, Act)

Regulatory Requirements in Quality Management

  • FDA Quality System Regulation (QSR)
  • ISO 13485:2016
  • ISO 9001:2015

Statistical basics

  • Check sheets/tally sheets
  • Descriptive statistics
  • Binomial Distribution (discrete data)
  • Hypergeometric Distribution (sampling without replacement)
  • Normal Distribution (continuous data)

Statistical Basics (cont’d)

  • Graphical Techniques:
    • Histograms
    • Scatterplots
    • Pareto charts
    • Cause and effect (fishbone) diagrams
    • Defect concentration diagrams

Q&A and Wrap-up

DAY 2 : (9 AM – 4.30 PM)

Statistical Process Control: The ABC’s of Control Charts

  • Elements of a control chart
  • Control Charts for Discrete Data
    • c chart
    • u chart
    • p chart
    • np chart
  • Control Charts for Continuous Data
    • X-bar chart
    • R chart
    • I chart
    • MR chart
    • Combined charts (Xbar-R, I-MR)

Statistical Process Control (cont’d)

  • More Control Charts
    • Classical Shewhart control charts
    • Cumulative Sum (CUSUM) charts
    • Exponentially Weighted Moving Average (EWMA) charts
    • Hotelling (multivariate) control charts

Statistical Quality Control – Attribute Sampling Plans

  • C= 0 /Zero Acceptance
  • Single sample plan
  • Double-sampling plan
  • Multiple sampling plan
  • Sequential sampling plan
  • Skip-lot sampling plan
  • Using ANSI Z1.4

Statistical Quality Control – Variables Sampling Plans

  • Sampling size and critical distance
  • Known vs. unknown standard deviation
  • One or two specification limits
  • Using ANSI Z1.9

Final Thoughts, Q&A and Wrap-up

San Diego, CA, USA

PRICING OPTIONS

For Single Delegate – $ 1200(Save $ 300 on Early Bird Discount)
Regular Price – $ 1500
Get 10% Discount on Group of 3 Delegates – $ 1080 / Delegate on Early Bird Offer (Save $ 1260)
Get 20% Discount on Group of 5 Delegates – $ 960 / Delegate on Early Bird Offer (Save $ 2700)

EARLY BIRD OFFERS CLOSES ON NOVEMBER 27, 2019

Early bird seats are limited and based on first-come, first-serve.

For discounts on multiple registrations, contact customer care at +1-416-915-4458

Register


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San Diego, CA
December 12 – 13, 2019
Venue to be announced

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 at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458 Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

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

Cancellation & Refund Policy:

Written cancellations through 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 – minus 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 (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

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

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If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

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