Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

WHY YOU SHOULD ATTEND:

This training is essential for professionals who:

• Need to conduct root cause investigations effectively.
• Want to ensure CAPA plans are sustainable and meet FDA expectations.
• Are involved in quality, compliance, risk management, or process improvement.
• Seek to minimize recurring issues and optimize organizational efficiency.
• Require an in-depth understanding of regulatory expectations for RCA and CAPA.

This expanded course transforms theoretical knowledge into actionable skills, ensuring participants can successfully conduct root cause investigations, implement CAPAs effectively, and verify their success through robust effectiveness checks. By the end of the training, attendees will have the expertise to improve compliance, minimize recurring issues, and enhance overall quality performance within their organizations.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Operations Departments
• Production Departments
• Compliance Departments
• Regulatory Affairs Departments
• Engineering Departments
• Manufacturing Departments
• Process Improvement Teams 
• Continuous Improvement Teams
• Risk & Safety Professionals
• Team Leaders & Supervisors
• Maintenance Staff
• Project Managers & Personnel

DAY 1 (9 AM to 2 PM)

Root Cause Analysis (RCA)

• Introduction to RCA, CAPA, and Effectiveness Checks
• Regulatory Expectations & Risks of Ineffective RCA
• RCA Tools & Techniques - Part 1: 5 Whys (Exercise: Apply 5 Whys to real-world scenarios)
• RCA Tools & Techniques - Part 2: Fishbone Diagrams (Exercise: Construct Fishbone Diagrams for quality failures)
• Advanced RCA Tools: Pareto Analysis & Is/Is Not Analysis (Case study analysis)
• Wrap-Up Discussion & Q&A

DAY 2 (9 AM to 2 PM)

CAPA & Effectiveness Checks

• Understanding CAPA & Common Mistakes in Implementation
• Developing Strong CAPA Plans & Ensuring Corrective Actions Work (Real-world case studies)
• Performing an Effective Effectiveness Check (Workshop: Design an effectiveness check process)
• Group Activity: Conduct RCA, Propose CAPAs, and Design Effectiveness Checks
• Final Q&A & Takeaways

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.