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!

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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

    • NEW! Statistical Elements of Post Market Clinical Follow-Up (PMCF)
    • Biostatistics for the Non-Statistician
    • Statistics for Process and Quality Control
    • Clinical Data Management
    • Fundamentals of Clinical Trial Design
    • Introduction to Adaptive Design

     


6-Hour Virtual Webinars:

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


2-Hour Virtual Webinars:

• Hypothesis Testing, P-Values, and Inference: When Thinking Like a Statistician Makes Sense
• Multiple Imputation for Missing Data
• Power Analysis and Sample Size
• Preparing a Statistical Analysis Plan
• MedDRA Basics
• Probability Basics
• Statistical Elements of Real-Time qPCR 

 


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


 
 

6-Hour Virtual Webinar: Statistics for Process Control

October 15, 2020

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

October 22, 2020

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.

6-Hour Virtual Webinar: Biostatistics for the Non-Statistician

October 29, 2020

Learn More About the Biostatistics for the Non-Statistician Webinar

Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This webinar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the webinar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

6-Hour Virtual Webinar: Statistics for Process Control

November 5, 2020

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: Regression and Beyond! Elements of Predictive Modeling in R

November 12, 2020

Learn More About the Predictive Modeling Primer: Regression and Beyond Webinar

Predicting future outcomes, the next steps in a process, or the best choice(s) from an array of possibilities are all essential needs in many fields. The predictive model is used as a decision making tool in advertising and marketing, meteorology, economics, insurance, health care, engineering, and would probably be useful in your work too!

Join Elaine Eisenbeisz of Omega Statistics as she presents the rationale and risks of predictive modeling via supervised learning techniques. Elaine will also provide an overview of some of the many available modeling techniques with associated R code including:

• Linear regression • Logistic regression • Linear discriminant analysis • K-Nearest Neighbors • Resampling methods (Cross-Validation, Bootstrap) • Subset selection • Shrinkage methods (Ridge regression, Lasso regression) • Tree-Based methods (Decision trees, Bagging, Random Forests, Boosting)

Statistical Elements of Post Market Clinical Follow-up (PMCF)

December 2, 2020

Learn More About the Statistical Elements of PMCF Webinar

The EU MDR 2017/745 includes new standards for CE marking of devices in the EU, one of the new standards is for the development and execution of a Post Marketing Clinical Follow-up plan. (PMCF).

PMCF is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post market surveillance plan.

When conducting PMCF, the manufacturer should proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market. The aim of PMCF is to confirm the safety and performance throughout the expected lifetime of the device, and to ensure the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. The focus of this webinar is to provide the statistical understanding and information needed to design and report a post-market clinical follow-up (PMCF) study. Making use of The MDCG 2020-1 Post market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies (April, 2020), participants will learn how to develop a PMCF plan and conduct data collection and interpretation for the PCMF clinical evaluation report.

2-Day Virtual Seminar: Clinical Data Management (FDA E6 GCP Guidelines)

December 10 and 11, 2020

Learn More About the Clinical Data Management Seminar

Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of CDM that apply across the board. Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan. The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.

Examples of CRF’s and required documentation will be presented. Data collection and preparation techniques will also be demonstrated, and will include the use of CDISC and SDTM standards. Additionally, this workshop will provide you with the knowledge and tools needed to assure a CDM plan that holds up when the inevitable deviations from protocol occur.

6-Hour Virtual Webinar: Biostatistics for the Non-Statistician

January 20th, 2021

Learn More About the Biostatistics for the Non-Statistician Webinar

Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This webinar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the webinar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

Join the Stats for the Masses mailing list to receive the “Stats Grab Bag” email with useful resources and links relating to the work I do each week. I like to think of it as tidbits from practice. You’ll never know what you’ll get, but it could be just what you need!

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Mailing Address

40960 California Oaks Road
Suite 215
Murrieta, CA 92592

Office Hours

8:00am until 5:00pm
Monday through Friday
[email protected]

Phone

951-461-7226
877-461-7226
Fax: 951-461-7339


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