1. CAPA Best Practices Open Discussion
MWDG May 2007 Meeting
CAPA Best Practices
Open Discussion

2. Agenda Introduction of new faces – 10 min (Jon Speer)
Overview of meeting format – 10 min (Jon Speer)
High level review of 2005 FDA CAPA Cites – 15 min (John Freije)
Breakout Groups Open Discussion on CAPA Best Practices – 50 min
Summary of Breakout Groups – 20 min (John Freije)
Wrap up / Meeting format feedback – 15 min (Jon Speer)

3. Meeting Format Open discussion in small breakout groups
Understand some redundancy in discussions
Pair with the individuals having the same color dot as you
Each group selects a scribe for note taking
Six high level topics on CAPA for group discussion

4. Data Analysis Analysis of data from FDA’s Turbo EIR database
Time frame 1/1/2005 to 12/31/2005
3872 observations were cited on the FDA-483s for 21 CFR 820 deficiencies
243 observations were cited for 21 CFR 803 deficiencies
45 observations were cited for 21 CFR 806 deficiencies
6 observations were cited for 21 CFR 821 deficiencies

5. Number of Observations (n=3872) 1/1/2005 to 12/31/2005

6. Observations by Subsystem 1/1/05 to 12/31/05

7. CAPA Observations by CFR citation – 2005

8. CAPA Observations
(109) Failure to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data - § (a)(1).
(40) Failure to investigate the cause of nonconformities - § (a)(2).
(61) Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems - § (a)(3).
(40) Failure to verify or validate the corrective and/ or preventive action to ensure it is effective - § (a)(4).
(14) Failure to implement changes to correct/prevent quality problems - § (a)(5).
(9) Failure to disseminate information related to quality problems or nonconforming product to those directly responsible for assuring the quality of the such product - § (a)(6).
(12) Failure to submit relevant CAPA information for Management Review - § (a)(7).
(126) Failure to document all activities required under this part - § (b).
85/ Warning Letters contained cites for CAPA deficiencies

9. CAPA Topic #1 How do you feel your company is using CAPA? Too much
Too Little
Just right

10. CAPA Topic #2
Does your company analyze the following? (if they are how?)
Processes
Work operations
Concessions
Quality audits
Records, etc 10

11. CAPA Topic #3
What tools/approach does your company use to conduct Root Cause or are they conducting Root Cause? 11

12. CAPA Topic #4
Does your company take a risk based approach to determine if a CAPA or trending is needed? 12

13. CAPA Topic #5 How does your company check for effectiveness?
How is it determined effective
When do you check it
What tools are used 13

14. CAPA Topic #6
Do your CAPAs only look at nonconforming products or poor processes? 14

15. Wrap Up/Feedback
Summary of discussions
Feedback on meeting format