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Conducting Bulletproof CAPA Investigations — ADVANCED Agenda

Conducting Bulletproof CAPA Investigations – Advanced
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause
Agenda

DAY ONE

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

FDA Regulatory Requirements and Enforcement

  • Patient safety is our number-one concern
  • Review of FDA requirements
  • Corrective and preventive action terms
  • Recent FDA inspection and enforcement trends
  • Required FDA notifications
  • Interactive Exercise! What’s Driving Us Crazy?

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Problem Solving and Investigations

  • Identifying and reporting problems quickly
  • Initial risk assessment
  • Determining need for an investigation
  • Problem statements and key steps
  • Six solution criteria
  • Creative-problem solving techniques
  • Interactive Exercise! Analyze cases and determine risks and need for an investigation; draft investigation plan if needed

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Root Cause Analysis Refresher

  • Brief review of common tools: Ishikawa diagram, flow charts, 5 whys, Is/Is not, cause and effect charts
  • Root cause analysis process
  • Tips on determining root causes and probable root causes
  • Data visualization techniques
  • Collaborative analysis
  • Interactive Exercise! Brainstorm root causes for real cases with peers  

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:45 p.m.

Interviewing and Writing

  • Interviewing techniques
  • Writing truths and tips
  • Critical thinking in a nutshell
  • Review portions of audiovisual program FDA uses to train its investigators on interviewing employees and management
  • Interactive Exercise! Practice identifying problem statement
  • Interactive Exercise! Practice interviewing a peer

4:45 p.m. – 5:00 p.m.

Lightning Round

Evening Work

Compliance Program Guidance Manual and Warning Letter

DAY TWO

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Best Practices

  • Discussion of insights from evening assignment
  • Brief review of investigation tips and techniques used by other industries
  • Discussion on data sources, root cause determination, effectiveness checks, timeliness, computerized systems and other critical issues
  • Interactive Exercise! Best practices exercise in small groups

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Critical-Thinking and Decision-Making

  • Key elements of critical thinking
  • Avoiding analytical traps
  • Logic, argument and risk assessment
  • Considerations in making good decisions
  • Preparing to defend your thinking and recommendations
  • Interactive Exercise! Practice using critical-thinking skills with peers on a case  

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Advanced Writing and Corrective and Preventive Action

  • Detailed suggestions for crafting and writing reports and summaries. Writing is “thinking on paper,” as revered writer and teacher William Zinsser says
  • Correcting detected problems
  • Preventing problems from occurring, including at other sites
  • Bullet-proofing your work
  • Communication to all affected sites or suppliers
  • Interactive Exercise! Review cases and develop possible corrective and preventive actions

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:45 p.m.

Major Case Development

  • Determining risk and urgency of problem
  • Determining if an investigation is needed
  • Using flow chart to understand the manufacturing, clinical, QA/QC, or other process involved
  • Identifying possible root causes and documenting them
  • Developing possible corrective and preventive actions, and effectiveness checks for each
  • Interactive Exercise! Discuss selected case and present findings and recommendations to class

4:45 p.m. – 5:00 p.m.

Review and Key Insights