Business Intelligence Solutions 18007820580 wwwbusintellsolcom - PDF document

1 13 0 Business Intelligence Soluti
13 0 Business Intelligence Solutions | 1.800.782.0580 | www.busintellsol.com 5 Steps to

2 Successful CAPA Process • Correctiv
Successful CAPA Process • Corrective and Preventive Action 5 Steps to Successful CAPA

3 Process 9 9 Agenda  Wha
Process 9 9 Agenda  What is Corrective and Preventive Action  Five Steps

4 to a Successful CAPA Process  Iden
to a Successful CAPA Process  Identify  Implement  Verify  Review 

5 Analyze  Conclusion What is CA
Analyze  Conclusion What is CAPA • Corrective and Preventive Action •

6 A concept found with Good Manufacturin
A concept found with Good Manufacturing Practice (GMP) , Corrective and Preventive Actions is

7 comprised of two important sub - system
comprised of two important sub - systems. • Corrective Action addresses a nonconformance

8 issue that has happened in the past in
issue that has happened in the past in order to prevent its recurrence. • Preventive Ac

9 tion however, focuses on preventing a di
tion however, focuses on preventing a discrepancy from occurring in the future. CAPA

10 Process Map CAPA Process Map CAPA Pr
Process Map CAPA Process Map CAPA Process Map CAPA Process Map 10 • Five Step Approa

11 ch Where Companies Have Difficulty 1
ch Where Companies Have Difficulty 13 Why? Incorrect Root Cause Identified! CAPA Su

12 bsystems More than 50% of the Wa
bsystems More than 50% of the Warning Letters and Form 483s issued by the FDA are for C

13 APA violations! 13 0 Busines
APA violations! 13 0 Business Intelligence Solutions | 1.800.782.0580 | www.busintell