In this program, we will discuss the common statistics tools and techniques used in validation. Through real-world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.
WHY SHOULD YOU ATTEND?
This webinar will be useful to validation engineers, R&D scientists, quality professionals, and production personnel involved in validation activities. Validation professionals in both medical device and pharmaceutical industries will benefit.
A basic understanding of statistics and the application to validation is vital to anyone involved in validation activities
AREA COVERED
- Introduction
- What is Statistics?
- Why do you need Statistics for Validation?
- Regulatory expectations
- The Concept of Variance (and why it is important)
- Sources of variance
- Measuring variance
- Normal and non-normal distributions
- Expressing Variance
- Variance
- Standard deviation
- Interactive exercise: Measuring Variance
- Coefficient of variation
- Process Capability
- Can your system do what you want (need) it to do?
- Measuring capability
- Using the capability to set acceptance criteria for validation
- Conclusion and Discussion
WHO WILL BENEFIT?
- Quality Assurance Professionals
- R&D Scientists
- Technical Support Scientists
- Regulatory Affairs Professionals
- Manufacturing and Production Personnel involved in validation activities
This webinar will be useful to validation engineers, R&D scientists, quality professionals, and production personnel involved in validation activities. Validation professionals in both medical device and pharmaceutical industries will benefit.
A basic understanding of statistics and the application to validation is vital to anyone involved in validation activities
- Introduction
- What is Statistics?
- Why do you need Statistics for Validation?
- Regulatory expectations
- The Concept of Variance (and why it is important)
- Sources of variance
- Measuring variance
- Normal and non-normal distributions
- Expressing Variance
- Variance
- Standard deviation
- Interactive exercise: Measuring Variance
- Coefficient of variation
- Process Capability
- Can your system do what you want (need) it to do?
- Measuring capability
- Using the capability to set acceptance criteria for validation
- Conclusion and Discussion
- Quality Assurance Professionals
- R&D Scientists
- Technical Support Scientists
- Regulatory Affairs Professionals
- Manufacturing and Production Personnel involved in validation activities
Speaker Profile

Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.Alan’s quality assurance experience extends from design control, change control, risk …
Upcoming Webinars

The Importance of the first 5 seconds when presenting

Project Management for administrative professionals

How to Reduce Human Error in a GMP Manufacturing Floor

Trump’s Executive Orders on DEI and Disparate Impact, and t…

How Accountants Can Use Chat GPT Effectively


The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…

Pivot tables beginner to advanced + 20 advanced Pivot table…

Changing Behavior: Why Rewards and Punishments Often Aren't…

Launch Your Career: The Ultimate Guide for Emerging Profess…

ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT

Managing Toxic & Other Employees Who Have Attitude Issues

Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…

Effectively Handle Toxic People for Better Productivity and…

Re-imagine Finance & Accounting Made Simple. Three Webinars…

Employee Handbooks: 2025 Critical Issues

Better Business Writing-How to Write Right

The five qualities every successful leader must develop



How to Lead and Manage a Narcissistic Employee

Use of AI and GPT for Finance Professionals

ChatGPT and Project Management: Leveraging AI for Project M…

Analytical Method Validation Under Good Laboratory Practic…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…

Excel What-If-Analysis Decision-Making Tools

How to Write Contracts for Procurement Professionals

Maximizing Productivity with ChatGPT: AI Solutions for HR, …

I-9 Audits: Strengthening Your Immigration Compliance Strat…

Dealing With Difficult People: At Work & In Life

Excel - Reporting Simplified - Learn Pivot Tables from Scra…



Retention Starts Here: Stop Losing Your Critical Talent and…

Turning Workplace Conflict into Positive Connection

Project Management for Non-Project Managers - How to commun…


The Business Case for LGBTQIA+ Inclusion in the Workplace: …

Conquer Toxic People - Learn To Protect Yourself And Get Yo…


AI-Powered Change Leadership Operationalizing AI: Practical…

AI and Human Resources: The Great Opportunity!

Cyber Security Incident Response Team Training Program

Transforming Anger And Conflict Into Collaborative Problem …


The Courage to Speak: Overcoming Fear and Owning the Room

Finance & Accounting 101 Simplified

6-Hour Virtual Boot Camp on Microsoft Power BI