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
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
Zero Acceptance Sampling to Reduce Inspection Costs
Project Management for Non-Project Managers - How to commun…
Why EBITDA Doesn't Spell Cash Flow and What Does?
FDA Compliance And Laboratory Computer System Validation
Workplace Investigations 101: How to Conduct your Investiga…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Human Error Trends as AI Enters GMP Operations: What QA Lea…
2026 EEOC & Employers: Investigating Claims of Harassment …
Stop Letting Toxic People Control Your Day
AI for Excel Professionals: Enhancing Productivity with Cha…
Building a High-Performance Team in 90 Days
Introduction to Microsoft Power BI Dashboards
Bootcamp for New Managers and Supervisors: Develop These Es…
Dealing with Difficult People: Managing Strong Personalitie…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Stop Letting That Difficult Person Ruin Your Day: Effective…
Reinvent Your HR Department with ChatGPT
Using Claude in Excel for Productivity, Automation & Data A…
DOL Reverses Course on Independent Contractor Rule for 2026…
FDA Technology Modernization Action Plan (TMAP) and Impact …
GROUPBY and PIVOTBY functions. Pivot table killers?
Discover how Emotional Intelligence turns AI from a technic…
Sunshine Act Reporting - Clarification for Clinical Research
FDA Recommendations for Artificial Intelligence/Machine Lea…
Cleanroom, Microbiology and Sterility Assurance Practices f…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FDA Audit Best Practices - Do's and Don'ts
Medical Device Hazard analysis following ISO 14971
Interactive dashboards & analytics in Excel