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 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

Female to Female Hostility @Workplace: All you Need to Know

Maximizing Productivity with ChatGPT: AI Solutions for HR, …



2-Hour Virtual Seminar on Empowering Presentations with Pow…

Pivot tables beginner to advanced + 20 advanced Pivot table…

Understanding Artificial Intelligence (AI) & using Chat GPT

Creating Loyal Customers Through Excellent Customer Service

Understanding and Communication New Immigration Policies (2…

Navigating Talent Management and Retention Strategies.

HIPAA is Unsettled – Safe Compliance Strategies

Project Management for Non-Project Managers - Scheduling yo…

How to Prepare For and Host a FDA Inspection and Respond to…

Empowering Conflict Resolution: Letting Go to Gain Control

Onboarding Best Practices for 2025: Proven Strategies to Po…

Navigating 2025 Employment Laws: What Every Employer Needs …


Managing Toxic Employees: Strategies For Leaders To Effecti…

How to Conduct Exit Interviews - Implementing and Enhancing…

Adapting to Change: Strategies for Personal & Team Resilien…

Introduction to Excels Built-In Solver – Advanced Decision-…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

FDA Technology Modernization Action Plan (TMAP) and Impact …

Design Control for Medical Devices Including Verification/V…

Stress, Change And Team Resilience Through Humor: An Intera…


Developing and Implementing Quality Culture in the Organiza…

GROUPBY and PIVOTBY functions. Pivot table killers?


Negotiating Skills For Professional Results - Winning Strat…

Use the power of AI to turbocharge your MS Excel


Trust in Leadership: Building and Maintaining Trust as a Le…

Conquer Toxic People - Learn To Protect Yourself And Get Yo…

Excel - Pivot Tables - The Key To Modern Data Analysis and …

AI and Human Resources: The Great Opportunity!

Tools and Tactics for Grieving, Surviving, and Thriving in …

Bootcamp for New Managers and Supervisors: Develop These Es…

How To Conduct An Internal Harassment And Bullying Investig…

How Generative AI can be used in Banking Risk and Compliance

Creating Employee Handbooks that Protect You and Support th…

Excel Power Skills: Master Functions, Formulas, and Macros …

Emotional Intelligence: Mastering the Emotions of Great Lea…

Managing Toxic & Other Employees Who Have Attitude Issues


The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

SOPs - How to Write Them to Satisfy those Inspectors

Improving Employee Engagement & Retention Through Stay Inte…


How to Give Corrective Feedback: The CARE Model - Eliminati…