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CAPA Best Practices Open Discussion

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Presentation on theme: "CAPA Best Practices Open Discussion"— Presentation transcript:

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

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