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

Dealing With Difficult People In Life & Work

How to Write Effective Audit Observations: The Principles f…

How to Document Employee Discussions and Why it is Important

OSHA Requirements for Supervisors, Project Leaders & HR - W…

FDA Compliance And Laboratory Computer System Validation

4-Hour Virtual Seminar on Transformational Leadership - The…

3-Hour Virtual Boot Camp on Easier Excel Automation with VB…


2025 Handbook Overhaul: Navigating Critical Updates! Federa…

Negotiating Skills For Professional Results - Winning Strat…

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…

Building Thriving Teams: Proactive Strategies for Managers …

Designing Employee Experiences to Build a Culture of Compli…

President Trumps Executive Orders And What They Mean to Emp…

Empowering Conflict Resolution: Letting Go to Gain Control

The Anti-Kickback Statute: 2025 - Year in Review

Navigating Alcohol and Drug Addiction Protections Under the…

50+ new Excel features so far this decade

FDA Technology Modernization Action Plan (TMAP) and Impact …

Form W-9 Compliance: TIN Verification, B Notices, and Avoid…

Workplace Investigations 101: How to Conduct your Investiga…

From Challenges to Compliance: Understanding Dietary Supple…


FDA Regulation of Artificial Intelligence/ Machine Learning

Utilizing HR Metrics to Illustrate & Improve Human Resource…

Outlook - Master your Mailbox - Inbox Hero Inbox Zero


Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Importance of the first 5 seconds when presenting

Do's and Don'ts of Documenting Employee Behaviour, Performa…

Why EBITDA Doesn't Spell Cash Flow and What Does

Understanding the incredible uses and fallbacks of ChatGPT

Mastering Performance Management: Strategies for Continuous…

The Monte Carlo Simulations in Excel for Risky Investments


Impact Assessments For Supplier Change Notices

Navigating FDA Regulations – A guide for medical device and…

California Meal and Rest Breaks: What You Don't Know Can Co…

Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…


Onboarding is NOT Orientation - How to Improve the New Empl…


Gossip-Free: Leadership Techniques to Quell Office Chatter

Female to Female Hostility @Workplace: All you Need to Know


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

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…


2025 Top Employment Regulations That Will Impact Employers!

Building GMP Excellence: A Guide to Implementing Compliant …