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
From Challenges to Compliance: Understanding Dietary Supple…
How To Conduct An Internal Harassment And Bullying Investig…
Improving Employee Engagement & Retention Through Stay Inte…
Using Behavior Based Interviewing for Finding the Best Matc…
Leadership: Strategic Planning and Decision Making
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Documenting Employee Behaviour, Performa…
De-Stressing Your Leadership for Greater Impact
Emotional Intelligence: Mastering the Emotions of Great Lea…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
How to Conduct Exit Interviews - Implementing and Enhancing…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Finance & Accounting 101 Simplified
Understanding How To Write A Compliant CAPAs
Mastering the Candidate Experience in Talent Acquisition.
4-Hour Virtual Seminar on Transformational Leadership - The…
Uplifting the Credibility of HR: How to Build the Credibili…
Treasury Risk Management, Funding, Liquidity, Interest Rate…
Courts No Longer Have to Give Deference to Agency’s “Expert…
21 CFR Part 820 - Quality System Regulation - Applying Prin…
Building Fair Chance Hiring Policies in 2024
HIPAA Bootcamp for Health Care Providers, Professionals, an…
Building GMP Excellence: A Guide to Implementing Compliant …
FDA Technology Modernization Action Plan (TMAP) and Impact …
Weathering the Storm: Navigating Resource Constrained Waters
How to Survive an Emotionally Toxic Workplace
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Excel Power Skills: Master Functions, Formulas, and Macros …
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Understanding the Artificial Intelligence Landscape
Employee Handbook Requirements for 2024. Includes Updated F…
Essential Job Functions According to the American with Disa…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
FDA Audit Best Practices - Do's and Don'ts
Engineering Change Management (ECM)
Batch Record Review and Product Release
Workplace Investigations 101: How to Conduct your Investiga…