Conducting Bulletproof CAPA Investigations — ADVANCED Agenda

DAY ONE (March 30, 2009/Sept. 24, 2009)

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:30 a.m.

Regulatory Requirements and Expectations

  • Review of FDA requirements
  • How the FDA trains its investigators to review investigations and CAPA
  • What’s driving us crazy?
  • Review of recent FDA warning letter citations/FDA 483 observations
  • Practice planning an investigation with a small group

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Refresher: How to Conduct a Bulletproof Investigation

  • 22 investigation tips
  • Crafting a clear, complete problem statement
  • The investigation plan
  • Analyze real industry case and prepare fishbone diagram

 

12:00 p.m. – 1:00 p.m.

:Lunch

1:00 p.m. – 2:00 p.m.

  • Root Cause Analysis

    •How to conduct and document a rootcause analysis
    •Six solution criteria
    •Practice brainstorming rootcauses for a real investigation

2:00 p.m. – 3:00 p.m.

Report Writing

  • Using critical thinking when evaluating reports
  • Typical content and structure
  • Tips on crafting the executive summary
  • Review and discussion of mock reports with peer

3:00 p.m. – 3:15 p.m.

Break

3:15 p.m. – 5:00 p.m.

Interviewing

  • Refresher on key interviewing skills
  • Review of portions of audiovisual program the FDA uses to train its investigators in interviewing techniques
  • Practice interviewing a peer

DAY TWO (March 31, 2009/Sept. 25, 2009)

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:30 a.m.

Managing CAPA

  • Tips from law enforcement
  • Selecting, training and coaching employees
  • CAPA inputs/tips on picking up important signals
  • Best practices exercise with small groups

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Risk Management as it Applies toCAPA

  • Patient safety: number one concern
  • Risk analysis techniques
  • Practice analyzing the risk of different scenarios

12:00 p.m. – 1:00 p.m.

Lunch
1:00 p.m. – 2:00 p.m.

Preventive Action, Crisis Management and Crisis Prevention

  • Encouraging preventive action
  • Key crises to prepare for (and how)
  • Developing a preventive action plan for real scenario, working with a team
2:00 p.m. – 3:00 p.m.

Required FDA Notifications

  • Refresher on requirements and timelines
  • Recalls, corrections and removals
  • Field alerts, medical device reports, biologic product deviation reports, adverse events and serious adverse events
  • Review mock forms with peer

3:00 p.m. – 3:15 p.m.

Break
3:15 p.m. – 5:00 p.m.

Class Project

  • Conduct a mock investigation working with your team
  • Present your findings to the overall class
  • Review and complete brief quiz on key points of class