2-Day Pharmaceutical & Medical Device CAPA & Root Cause Analysis Training

Days: 2 

 7:30 AM- 4:30 PM MST

Learn Pharma & Medical Device CAPA

Come learn the FDA 21 CFR and ISO 13485 requirements for a regulatory-compliant CAPA system and records. You will leave this training knowing how to perform effective root cause investigations that address, resolve, and prevent the issue(s) from recurring. This same CAPA methodology can be used to address Regulatory audit findings throughout the world.

This course teaches:

✔ The regulatory requirements for pharmaceutical and medical device CAPA:

  • 21 CFR Part 4 – Good Manufacturing Practices for Combination Products
  • 21 CFR Part 820 – Quality System Regulations for Medical Devices; Good Manufacturing Practices for Devices
  • 21 CFR Part 801 – Labeling of Medical Devices
  • 21 CFR Part 201 – Labeling of Drugs
  • 21 CFR Part 210 and 211 – Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding Drugs
  • ISO 13485:2016 – Quality System Requirements for Medical Devices (and comparison to MDSAP and EU MDR/IVDR requirements)
  • EU MDR CAPA Requirements related to: Article 83 PMS, Article 10 Manufacturing, Article 89 Serious Incidents

✔ How to perform effective fast-paced root cause analysis and complaint investigations– no more “best-guesses”

✔ How to document complaint investigations and maintain records to demonstrate compliance

✔ Root cause investigation methods, such as:

  • The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys)
  • Fault Tree Analysis
  • Cause and Effect
  • Flow Charting
  • Pareto Charting
  • Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)
Fishbone Diagram - Pharma & Medical Device CAPA

✔ Other helpful pharma & medical device CAPA Tools including:

  • 5-W 2-H and 5-W 2-H Proof
  • FMEA
  • Containment approaches
  • Incident Risk Analysis
  • Paynter Charts
  • Layered Process Auditing
  • Corrective Action Plans
  • COPQ approach to CAPA profit enhancement

Learning Objectives:

  1. Learn and practice within a compliant corrective action & preventive action (CAPA) process.
  2. Learn how to perform effective root cause investigations.
  3. Learn and understand when and how to apply the appropriate root cause investigation tool/method.
  4. Learn and understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
  5. How to establish effective corrective action plans.
  6. How to plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
  7. Learn how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
  8. Learn how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
  9. Learn the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques

Who Should Attend

  • Do you do Corrective Actions? – THEN YOU SHOULD ATTEND!
  • Quality Engineers (QE)
  • Manufacturing Engineering (ME)
  • Process Engineers & Technicians
  • Electrical Engineers (EE) and Technicians
  • Top ManagementWhy? They are ultimately responsible for ensuring the CAPA system is working effectively.
  • Operations Directors & Management
  • Engineering Directors & Management
  • Marketing Directors & Management
  • Manufacturing Directors & Management
  • Regulatory Directors & Management
  • Quality Assurance Directors & Management
  • Purchasing Managers
  • Supply Chain Managers who deal with SCAR and CAR processes.
  • ANYONE WHO THINKS THEY KNOW MEDICAL DEVICE CAPA but really doesn’t get it, making them a prime target for a HUGE FDA finding that will ROCK their world and WASTE ALL SORTS of time and resources.

Class Agenda

Day 1

  • Overview – Why CAPAs are required
    • Overview of the Regulatory requirements for CAPA in the following countries:
    • USA (FDA)
    • Australia (TGA)
    • Brazil (ANVISA)
    • Canada (CMDR)
    • Japan (PMDA)
    • European Union (including BREXIT)
  • Typical Problems with Root Cause Investigations
    • Why most problem-solving models don’t get to the root cause and a solution
    • How analytical and creative thinking must be both separated and integrated
    • Difference between content and process thinking
  • Responsibilities for Root Cause and Corrective/ Preventive Action
    • Top Management, Operation Management, Marketing Management, Engineering, Quality, Design, Frontline Management, Supervisors, Worker
  • Step 1: Assigning a corrective action team leader: cross functional team
  • Step 2: Describing the problem – COPQ
    • Activity – Risk Ranking for Quality Events – Deciding: Proportionate to the Effects
    • Activity – Medical Device CAPA Case Study #1: What constitutes an effective CAPA?
    • Activity – Detailed problem descriptions
  • Step 3: Containing the problem
    • Case Study – CAPA Case Study #2: What is proper Containment of the problem?
  • Step 4: Identifying the root cause or causes
    • System, process, & product causes
    • Root cause/data investigation tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
  • Data Collection and Analysis
    • Check sheets, graphs, and tables for discrete data collection
    • Surveys, interviews, and field observation for opinions or less precise data
    • Activity – “5 Whys” method, 3×5 Whys, 5-Whys Tree
    • Activity – Ishikawa or Cause & Effect Diagram

Day 2

  • Step 5: Verifying the root cause or causes
    • Activity: Likely Cause Worksheet: CAPA Case Study #2
    • Activity: 5-W 2-H Proof: CAPA Case Study #2
    • Pareto or 80/20 Rule, I can’t work EVERY cause, which ones?
  • Step 6: Implementing corrective actions
    • Band-Aids vs Long-Term improvement: ST, IT and LT Corrective Actions
    • Corrective Action Plans: managing resources and achieving permanent improvement
  • Step 6a: Risk Assessment: verify CAPA does not impact regulatory or safety requirements
    • Risk Management Process: ISO 14971 MD application of Risk Management
    • Hazards, Hazardous Situations and Harms – keeping your device Safe and Effective
    • Determining Probability of a Hazardous Situation presenting itself (P1), and of a Harm resulting (P2)
    • Activity: FMEA for CAPA Case Study #2
  • Step 7: Verifying corrective action effectiveness
    • Production Process Audits: are proactive controls In-Place
    • Layered Process Auditing: Effecting permanent Change in your Organization
    • Crafting Effectiveness Check plans for each Corrective Action
    • Activity: Effectiveness Plan: CAPA Case Study #2
    • Paynter Charting: temporary Effectiveness Check
  • Step 8: Closing the Corrective Action – Finally ALL DONE
    • Considering Preventive Actions:
      • Preventive vs. Corrective Actions: FDA and Final Rule FDA 820 Considerations
      • FMEAs – it’s all Preventive or Proactive
      • 3×5 Whys and “Read Across”
    • Congratulate the TEAM!
  • Course Insights and Final Exam