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
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Launch Your Career: The Ultimate Guide for Emerging Profess…
Moving From an Operational Manager to a Strategic Leader
Discover how Emotional Intelligence turns AI from a technic…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Empowering Conflict Resolution: Letting Go to Gain Control
The 60 Minutes Introduction to DAX
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Giving Effective Feedback for Performanc…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Copilot and HR: An Introduction for HR Professionals
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Major cGMP Issues: FDA Concerns in 2026
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding EBITDA – Definition, Formula & Calculation
DOL Reverses Course on Independent Contractor Rule for 2026…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT and Project Management: Leveraging AI for Project M…
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
Negotiating Skills For Professional Results - Winning Strat…
Managing Projects When AI Joins the Team: Human Judgment, A…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Fatal Errors Employers Make When Updating Employee Handbook…
AI Fundamentals for All Leaders and Managers: How to Work S…