Statistical Elements of Implementing ICH Guidelines

"Statistical Elements of Implementing ICH Guidelines" Seminar has been added to ComplianceOnline.com's offering.

SAN JOSE, CA, UNITED STATES, December 20, 2021 /EINPresswire.com/ -- ComplianceOnline, the leading provider of regulatory compliance training, announced a new educational seminar for quality functions of pharmaceutical and biotechnology companies on the topic ‘Statistical Elements of Implementing ICH Guidelines.’ The January 19-20, 2022 seminar is led by subject matter expert Elaine Eisenbeisz, offering attendees an understanding of the fourteen ICH Quality guidelines as they relate to statistical guidance and analysis.

Most organizations have programs and procedures but they contain holes or fall short in the implementation of the tools and techniques used to apply proper statistical reasoning and analysis to ICH guidelines. Statistics can help better understand, implement, and track processes covered by the ICH guidelines.

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate the risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

The course will provide tools, techniques and insight that will allow participants to immediately begin implementation of the information learned within their organization/firm.

According to the event overview, upon completion of the course, attendees will be able to:
• Compare FDA requirements to ICH guidelines.
• Perform comparative analyses and regression analysis.
• Know the difference between confidence and tolerance intervals.
• Calculate the appropriate sample size.
• Calculate the probability of risk.
• Define and implement a process characterization strategy

For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: January 19-20, 2022 (10:00 AM - 4:00 PM EST)

About the Speaker:

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.

About ComplianceOnline.com:

ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.

For more information on ComplianceOnline or to browse through our training programs, please visit the website.

Priyabrata Sahoo
ComplianceOnline
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