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 This course will also discuss the latest draft guidance from the FDA in regard to Quality Metrics.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This course will discuss the latest draft guidance from the FDA in regard to Quality Metrics.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Discuss the 2016 Draft Guidance from the FDA on Quality Metrics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This course will discuss the latest draft guidance from the FDA in regard to Quality Metrics.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
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
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
Design Verification, Validation and Testing for Medical Dev…
Project Management for Non-Project Managers - How to commun…
Why EBITDA Doesn't Spell Cash Flow and What Does
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Employee or Independent Contractor – U.S DOL Announces 2024…
How to Survive an Emotionally Toxic Workplace
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Best Practices in Complaint Management for Regulatory Compl…
Human Factors Usability Studies Following ISO 62366 and FDA…
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Tattoos, hijabs, piercings, and pink hair: The challenges …
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Divorce, Adoption and Other Special Tax Topics
Understanding and Analyzing Financial Statements
Setting up Quality System for FDA Regulated Products: Tips …
Is Your Culture Working For or Against Your Success? If You…
Design History File (DHF), the Device Master Record (DMR) a…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Documenting Misconduct that Will Stand Up in Court
Sunshine Act Reporting - Clarification for Clinical Research
Stress, Change And Team Resilience Through Humor: An Intera…
FDA Regulation of Artificial Intelligence/ Machine Learning
Managing Toxic & Other Employees Who have Attitude Issues
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Managing Complex Projects - Project Management
Patient Gifts, Discounts and Freebies: What You Can and Can…
All About Civility - Eliminating a Culture of Gossip Rumors…
From Challenges to Compliance: Understanding Dietary Supple…
Improving Employee Engagement & Retention Through Stay Inte…
How To Conduct An Internal Harassment And Bullying Investig…
Using Behavior Based Interviewing for Finding the Best Matc…
The Anti-Kickback Statute: Enforcement and Recent Updates
Leadership: Strategic Planning and Decision Making
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
How to Conduct Exit Interviews - Implementing and Enhancing…