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

Better Business Writing-How to Write Right

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

Effectively Handle Toxic People for Better Productivity and…



Employee Handbooks: 2025 Critical Issues

The five qualities every successful leader must develop

How to Lead and Manage a Narcissistic Employee

Use of AI and GPT for Finance Professionals

Data Privacy and Protection - Data protection laws and best…

ChatGPT and Project Management: Leveraging AI for Project M…

Excel What-If-Analysis Decision-Making Tools

How to Write Contracts for Procurement Professionals

Analytical Method Validation Under Good Laboratory Practic…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…

I-9 Audits: Strengthening Your Immigration Compliance Strat…

Maximizing Productivity with ChatGPT: AI Solutions for HR, …

Strategies For Job Seekers: Best Practices For A Strategic …

Dealing With Difficult People: At Work & In Life

Excel - Reporting Simplified - Learn Pivot Tables from Scra…



The Perfect Storm Coming to Healthcare: Value Based Care Me…

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

Turning Workplace Conflict into Positive Connection

Retention Starts Here: Stop Losing Your Critical Talent and…

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


AI and Human Resources: The Great Opportunity!

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

AI-Powered Change Leadership Operationalizing AI: Practical…


Cyber Security Incident Response Team Training Program



Transforming Anger And Conflict Into Collaborative Problem …

Excel Power Skills: Master Functions, Formulas, and Macros …

The Courage to Speak: Overcoming Fear and Owning the Room

6-Hour Virtual Boot Camp on Microsoft Power BI


Finance & Accounting 101 Simplified

6-Hour Virtual Seminar on Learning the Highlights of Excel …

Empowering Conflict Resolution: Letting Go to Gain Control


How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…

Human Error Reduction Techniques for Floor Supervisors

Secrets Of Psychology - Why People Do The Things They Do

How To Conduct An Internal Harassment And Bullying Investig…

Leadership: Strategic Planning and Decision Making

Marketing to Medicare or Medicaid Beneficiaries - What You …