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
Conflict Resolution - Prevent, De-escalate, Resolve
Female to Female Hostility @Workplace: All you Need to Know
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
When Employees Travel: Wage and Expense Rules Employers Mus…
Implementing an Effective Human Error Reduction Program
Validation Statistics for Non-Statisticians
Form 1099-MISC and 1099-NEC Compliance Update 2024
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Why EBITDA Doesn't Spell Cash Flow and What Does
The Totally Organized Professional Is All About Outcomes
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
How to Address ISO's New Climate Change Requirements
Re-imagine Finance & Accounting Made Simple. Three Webinars…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Project Management for HR, Administrative Professionals, an…
Tattoos, hijabs, piercings, and pink hair: The challenges …
How to Document Employee Discussions and Why it is Important
Using Behavior Based Interviewing for Finding the Best Matc…
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Best Practices for Working With Vendors and Suppliers
The Top Ten Excel Functions Everyone Should Know
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Kicking your Employee Retention Efforts into Overdrive: Sta…