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DAY ONE
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8:00 a.m. – 8:30 a.m.
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Registration/Continental Breakfast
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8:30 a.m. – 10:00 a.m.
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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?
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10:00 a.m. – 10:15 a.m.
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Break
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10:15 a.m. – 12:00 p.m.
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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
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12:00 p.m. – 1:00 p.m.
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Lunch
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1:00 p.m. – 2:30 p.m.
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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
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2:30 p.m. – 2:45 p.m.
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Break
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2:45 p.m. – 4:45 p.m.
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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
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4:45 p.m. – 5:00 p.m.
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Lightning Round
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Evening Work
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Compliance Program Guidance Manual and Warning Letter
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DAY TWO
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8:00 a.m. – 8:30 a.m.
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Registration/Continental Breakfast
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8:30 a.m. – 10:00 a.m.
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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
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10:00 a.m. – 10:15 a.m.
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Break
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10:15 a.m. – 12:00 p.m.
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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
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12:00 p.m. – 1:00 p.m.
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Lunch
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1:00 p.m. – 2:30 p.m.
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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
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2:30 p.m. – 2:45 p.m.
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Break
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2:45 p.m. – 4:45 p.m.
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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
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4:45 p.m. – 5:00 p.m.
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Review and Key Insights
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