Elaine Eisenbeisz

Owner, Omega Statistics

Course Description

This 6-hour virtual seminar includes a presentation of 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 process control: obtaining monitoring 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.

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 monitoring tools within the statistical framework.

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

Process control is 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.

Why Should You 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) allows us to control the functions of our processes (input) by providing tangible monitoring tools.

Process control is important for a company’s reputation. A good system of processing and checks reduces 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 process management system in place to achieve compliance with regulatory authorities.

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

Agenda

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
  • IS 9001:2015
  • Harmonization of regulations with FDA guidance/regulations

Statistical basics

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

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

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
FDA Faculty Elaine Eisenbeisz

Elaine Eisenbeisz

Statistician ( 30 + yrs exp.) 

Owner & Principal of Omega Statistics

Murrieta, California, United States

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. 

Choose a Pricing Option

$795

One Dial-in One Attendee - Live + 30 days Access

You get one log-in for the live virtual seminar for one participant & On Demand Recorded Access for 90 days , presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access for 30 days is included .

$3,495

Group-Max. 10 Attendees - Live + 90 days Access

You get Group log-in for the live virtual seminar for 10 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 90 days for the Group.

$795

Recorded Access Single Participant

You'll have 6 month access to single log-in for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$1,995

Recorded Access Group-Max. 10 Attendees

You'll have 12 month access to group log-in upto 10 attendees for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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