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

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Presentation on theme: "MWDG MWDG May 2007 Meeting CAPA Best Practices Open Discussion 1."— Presentation transcript:

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

2 MWDG 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) 2

3 MWDG 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 3

4 MWDG Data Analysis Analysis of data from FDAs Turbo EIR database Time frame 1/1/2005 to 12/31/ 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 4

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

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

7 MWDG CAPA Observations by CFR citation –

8 MWDG 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 8

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

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

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

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

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

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


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