Paid (Fee-Based) Events


Elaine Eisenbeisz, Owner and Principal Statistician of Omega Statistics, is available for training and workshops in statistics, clinical research, process control/quality assurance, and other topics related to statistics and good research practices. Please call or email the Omega Statistics offices to request the latest brochure and pricing for the event(s) that interests you.

Current offerings and scheduled events are listed below.

In addition to the current offerings listed below, Elaine can design an in-house training or virtual webinar to meet your specific needs. Just give her a call at 877-461-7226 or fill out the contact form on this page to leave her a message and she’ll contact you to schedule a time to discuss your needs and how she can help!

Skills Training

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Currently Available Offerings:

2-Day (In-Person or Virtual) Seminars/Workshops:

NOTE: In-person events are not being scheduled at this time

• Biostatistics for the Non-Statistician
• Statistics for Process and Quality Control
• Statistical Elements of Chemistry, Manufacturing, and Controls (CMC)
• Clinical Data Management
• Fundamentals of Clinical Trial Design
• Introduction to Adaptive Design

6-Hour Virtual Webinars:

• Biostatistics for the Non-Statistician
• Regression and Beyond! Elements of Predictive Modeling in R
• Statistics for Process Control
• Statistics for Quality Control
• Statistical Elements of Post Market Clinical Follow-Up (PMCF)
• Categorical Data Analysis

4-Hour Virtual Webinars:

• Multiple Linear Regression, Logistic Regression, and Survival Analysis
• Applied Time Series Analysis in Health Care
• Statistical Elements of PK/PD Analysis

90 Minute or 2-Hour Virtual Webinars:

• Hypothesis Testing, P-Values, and Inference: When Thinking Like a Statistician Makes Sense
• Is my Data Normal? Normality Tests and Transformations
• Multiple Imputation for Missing Data
• Power Analysis and Sample Size
• Equivalency and Non-Inferioirty Tests
• Preparing a Statistical Analysis Plan
• MedDRA Basics
• Probability Basics
• Statistical Elements of Real-Time qPCR
• Understanding Clinical Trial Reports
• Propensity Score Matching in Observational Studies
• Multiplicity: When and How to Adjust for Multiple Testing

• Calculations for Process and Product Capability
• Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
• Statistical Elements of Small Sample Sizes and Only 3 Lots in Process of Product Validation


Currently Scheduled Fee Based Events

Omega Statistics has contracted with 3rd party companies to present the following fee based events. The events are listed in chronological order. Please click on the links that interest you to learn more and to register.

Upcoming Events

90 Minute Virtual Webinar: Power Analysis for Sample Size Calculations

September 2, 2021

Learn More About the Power Analysis for Sample Size Calculations Webinar

The power of your study is the probability that you will find a statistically significant difference or relationship (an “effect”) if that difference or relationship (effect) truly exists in the population.

A study with too small of a sample size is under-powered. This means that even if the effect you are testing for truly exists, you won’t achieve statistical significance. You will waste time by collecting a sample that is too small to properly power a study. Why perform a research if you can’t see significance for your desired effect?

A study with too large of a sample is over-powered. This means that you’ve collected such a large sample that you will see significance even on very small effects. However, the costs of subject recruitment, data collection, and follow-up (if needed) are quite large. Recruiting more subjects than needed unnecessarily inflates the temporal and monetary costs.

Questions related to the feasibility of a study can be answered by power analysis:

  • How large of a sample will I need to collect in order to see a significant effect?
  • How many subjects will I need if I test an effect that is a bit larger? a bit smaller?
  • Answers to questions like these will give you an idea if your study is indeed “do-able.”

In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software.

6-Hour Virtual Webinar: Statistics for Process Control

September 16, 2021

Learn More About the Statistics for Process Control Webinar

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.

6-Hour Virtual Webinar: Statistics for Quality Control

September 23, 2021

Learn More About the Statistics for Quality Control Webinar

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 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 acceptance sampling systems and analytical 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 product in the medical device and pharmaceutical industries.

The application of quality control techniques 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.

90 Minute Webinar: Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

October 14, 2021

Learn More About the Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation Webinar

Regulatory and certification bodies have requirements for the validation of processes. 21 CFR Part 820.75 (a) Process validation states, ”Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” Additionally, ISO 9001:2008 7.5.2 Validation of processes for production and service provision states ”The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.”

100% testing in most manufacturing processes would require 100% destruction of the product being made. Therefore it is important to know the minimum amount of product to sample from a minimum number of lots in order to preserve inventory while minimizing risk (such as loss of product, consumer risk of defectives, etc.)

Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.

The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.

90 Minute Webinar: Calculations for Process and Product Capability

October 21, 2021

Learn More About the Calculations for Process and Product Capability Webinar

Companies involved on manufacturing and development perform inspection and testing for acceptance as relates to design, quality, or consumer criteria. These tests and inspections are performed on samples which may be collected at various times in the manufacturing process, including design verification, process validation, or quality control of incoming or outgoing product.

Attendees of this webinar will learn the theory, terminology, regulatory requirements, best practices, and of course, the formulas for calculating common process capability indices used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

90 Minute Webinar: Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

December 9, 2021

Learn More About the Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies Webinar

Verification and validation studies of design-outputs and/or manufacturing processes are required in many manufacturing processes. However, it can be difficult to understand the rational for same sizes used in these contexts. This webinar will be useful to those interested in learning how to make and justify the reasoning behind sample size determination.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Learn the theory, terminology, regulatory requirements, best practices, and of course, the steps for calculating sample sizes for process verification and validation.

NOTE: This webinar does not address rationales for sample sizes used in clinical trials.


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