Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the FDA in regard to Quality Metrics.
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture.
WHY SHOULD YOU ATTEND?
This course will discuss the latest draft guidance from the FDA in regard to Quality Metrics.
LEARNING OBJECTIVES
Establishing Appropriate Quality Metrics
- Understand why metrics are important to both individuals and management.
- Understand the difference between Key Performance Indicators (KPIs) and metrics.
- Review common Quality metrics and the associated mathematical equations.
- Discuss the use of dashboards.
- Discuss common errors associated with establishing metrics.
Driving Quality Culture through Appropriate Quality Metrics
- Understand that what gets measured will directly impact employee behaviors.
- Discuss how to ensure Quality metrics will result in the behaviors you want.
- Discuss how to utilize Quality metrics to improve both individual and company performance.
Discuss the 2016 Draft Guidance from the FDA on Quality Metrics
- Review the contents of the FDA guidance on Quality Metrics.
WHO WILL BENEFIT?
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
This course will discuss the latest draft guidance from the FDA in regard to Quality Metrics.
Establishing Appropriate Quality Metrics
- Understand why metrics are important to both individuals and management.
- Understand the difference between Key Performance Indicators (KPIs) and metrics.
- Review common Quality metrics and the associated mathematical equations.
- Discuss the use of dashboards.
- Discuss common errors associated with establishing metrics.
Driving Quality Culture through Appropriate Quality Metrics
- Understand that what gets measured will directly impact employee behaviors.
- Discuss how to ensure Quality metrics will result in the behaviors you want.
- Discuss how to utilize Quality metrics to improve both individual and company performance.
Discuss the 2016 Draft Guidance from the FDA on Quality Metrics
- Review the contents of the FDA guidance on Quality Metrics.
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
Speaker Profile
Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Upcoming Webinars
Do's and Don'ts of Documenting Employee Behaviour, Performa…
4-Hour Virtual Seminar on Audit Proofing your Payroll Opera…
Retention Starts Here: Stop Losing Your Critical Talent and…
Practice Safe Stress ™: Preventing Burnout While Building R…
Cleanroom, Microbiology and Sterility Assurance Practices f…
Impact Assessments For Supplier Change Notices
2-Hour Virtual Seminar on DeepSeek vs ChatGPT AI for CPAs a…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Understanding EBITDA – Definition, Formula & Calculation
How the OBBB Act will Impact Immigration Enforcement! Preve…
Construction Lending And Real Credit Administration: Evalua…
Sunshine Act Reporting - Clarification for Clinical Research
FDA Regulation of Artificial Intelligence/ Machine Learning
2-Hour Virtual Seminar on Outlook - Timesaving Tips and Tri…
H-1B Visa Updates and Employer Strategies for 2026
Leadership Upskilling: Don’t Just Manage; Lead with Influen…
Aligning Your HR Strategy with Your Business Strategy: A Ro…
HIPAA 2025 – Major Changes, Latest Rulings & Guidance
AI for Excel Professionals: Enhancing Productivity with Cha…
Dealing With Difficult People: At Work & In Life
Understanding Accounting for non - Accounting professionals
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Project Management for Non-Project Managers - Scheduling yo…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
ChatGPT and Project Management: Leveraging AI for Project M…
Excel Power Skills: Master Functions, Formulas, and Macros …