ComplianceOnline

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

The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.

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.

Process and quality control are constantly evolving. Therefore, historical concepts, current trends and regulatory requirements will be discussed. The presentation of statistical charts and analyses, graphical techniques for planning, trouble-shooting and problem solving will also be presented.

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

Instructions and Complementary Handouts:

  • Minitab statistical software will be used to demonstrate data collection and input, and how to build and interpret various process control charts for both attributes and variables data.
  • The seminar will also include the use of Minitab to develop attributes and variables sampling plans for quality assurance and acceptance.
  • A handout and dataset will be provided to attendees, so they may work hands-on with the information presented in the seminar.

Learning Objectives:

  • Understanding of the need and reasons for statistical process control
  • Knowledge of regulations and requirements of sound process control and acceptance sampling plans
  • Understanding and application of statistical concepts in the development and use of process control and sampling plans
  • Step-by-step instructions on how to design and interpret control charts and sampling plans using Minitab software

Areas Covered :

  • 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 will Benefit:

  • Quality assurance (QA) engineers
  • Quality control (QC) engineers
  • R&D engineers
  • Process control personnel
  • Manufacturing/Industrial personnel
  • Manufacturing/Industrial personnel
  • Production supervisors
  • Management personnel of processing facilities

Topic Background:

In pharma and medical device companies, 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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM -10:30 AM Introductions: Seminar objectives review, expectations and scope. Session 1(90 Mins): 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)
  • 10:30 AM -12:00 Noon Session 2(90 Mins): Regulatory Requirements in Quality Management
    • FDA Quality System Regulation (QSR)
    • ISO 13485:2016
    • ISO 9001:2015
  • 12:00 Noon-1:00 PM Lunch
  • 1:00 PM-2:30 PM Session (90 Mins): Statistical basics
    • Check sheets/tally sheets
    • Descriptive statistics
    • Binomial Distribution (discrete data)
    • Hypergeometric Distribution (sampling without replacement)
    • Normal Distribution (continuous data)
  • 2:30 PM-4:00 PM Session (90 Mins): Statistical Basics (cont’d)
    • Graphical Techniques:
      • Histograms
      • Scatterplots
      • Pareto charts
      • Cause and effect (fishbone) diagrams
      • Defect concentration diagrams
  • 4:00 PM-4:30 PM Wrap-up for Day 1, Q & A
Day 02(9:00 AM - 4:30 PM)
  • 9:00 AM-10:30 AM(90 Mins): 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)
  • 10:30 AM-12:00 Noon Session 2(90 Mins): 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
  • 12:00 Noon-1:00 PM Lunch
  • 1:00 PM-2:30 PM Session 3(90 Mins): 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
  • 2:30 PM-4:00 PM Session 4(90 Mins): 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
  • 4:00 PM - 4:30 PM: Final Thoughts, Wrap-up for Day 2, Q & A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Elaine Eisenbeisz

Elaine Eisenbeisz
Owner, Omega Statistics

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.

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Register Now

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$1,699.00

Seminar One Registration

June 13-14, 2019, Chicago, IL
(Registrations till May 27, 2019 - $1699)
(Registrations after May 27, 2019 - $1899)




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

The registration fee includes: the workshop; all related course materials; morning tea/coffee on both days, lunch and afternoon tea/coffee on day one.


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

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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:

Chicago, IL
(Venue to be announced shortly)

June 13-14, 2019

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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:

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Local Attractions of Chicago, IL

Windy

Windy

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

Adler Planetarium and Astronomy Museum

Adler Planetarium and Astronomy Museum

The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

Arlington International Racecourse

Arlington International Racecourse

With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

Art Institute of Chicago

Art Institute of Chicago

You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

Auditorium Building and Theatre

Auditorium Building and Theatre

A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

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