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

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)

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

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

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

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

CAPA Observations by CFR citation – 2005

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 - §820.100(a)(1). (40) Failure to investigate the cause of nonconformities - §820.100(a)(2). (61) Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems - §820.100(a)(3). (40) Failure to verify or validate the corrective and/ or preventive action to ensure it is effective - §820.100(a)(4). (14) Failure to implement changes to correct/prevent quality problems - §820.100(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 - §820.100(a)(6). (12) Failure to submit relevant CAPA information for Management Review - §820.100(a)(7). (126) Failure to document all activities required under this part - §820.100(b). 85/97 2005 Warning Letters contained cites for CAPA deficiencies

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

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

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

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

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

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

Wrap Up/Feedback Summary of discussions Feedback on meeting format