This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.
WHY SHOULD YOU ATTEND?
CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years’ experience. You will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems.
LEARNING OBJECTIVES
- Build the right team
- Develop a problem statement
- Failure Investigation
- Data Collection
- Analysis Tools and Techniques
- How tVerify your Results
- Real Lessons Learned
- Do’s and Don’ts of CAPA
- Best Practices
- Inspection Readiness
WHO WILL BENEFIT?
- Quality Engineers
- Manufacturing Engineers
- Process Engineers
- Compliance Specialists
- Auditors
- CAPA Specialists
- CAPA Project Leaders
- CAPA Managers
CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years’ experience. You will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems.
- Build the right team
- Develop a problem statement
- Failure Investigation
- Data Collection
- Analysis Tools and Techniques
- How tVerify your Results
- Real Lessons Learned
- Do’s and Don’ts of CAPA
- Best Practices
- Inspection Readiness
- Quality Engineers
- Manufacturing Engineers
- Process Engineers
- Compliance Specialists
- Auditors
- CAPA Specialists
- CAPA Project Leaders
- CAPA Managers
Speaker Profile
Susanne Manz
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a …
Upcoming Webinars
Aligning Your HR Strategy with Your Business Strategy: A Ro…
HIPAA 2025 – Major Changes, Latest Rulings & Guidance
Understanding Accounting for non - Accounting professionals
Dealing With Difficult People: At Work & In Life
2026 Employment Law Guide - Essential Updates Every Employe…
Project Management for Non-Project Managers - Scheduling yo…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
ChatGPT and Project Management: Leveraging AI for Project M…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Advanced Commercial Loan Underwriting Certification
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Copilot and HR: An Introduction for HR Professionals
Excel Power Skills: Master Functions, Formulas, and Macros …
Identifying, Managing, and Retaining High-Potential Employe…
Eliminate Harmful And Unproductive Drama In The Workplace
How to Write Effective Audit Observations: The Principles f…
Project Management for administrative professionals
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Mastering DAX Patterns in the Era of AI & Copilot
Building GMP Excellence: A Guide to Implementing Compliant …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
The Language of Leadership: Is Your Communication Style As …