CAPA for the FDA Regulated Industry

ACADEMIA LEAN SIGMA SC

Roberto Gonzlez

Herramientas Lean, Manejo de

proyectos, 8D, CAPA, Estadstica
Industrial, Seguridad Industrial

BIT Center Tijuana

Blvd. Daz Ordaz 12415 M5-2
Frac. El Paraso. C.p 22106
Tel. 664 380 6161

Overall Objective:
Upon completion of this course participants will be able to evalu-
ate their organizations compliance with FDAs requirements for
establishing a Corrective and Preventive Action system. Further,
they will be able to implement a compliant business value-added
CAPA system to effectively manage existing and potential product
and quality system nonconformities.
 Specific Objectives

Participants will obtain an understanding of: Topics covered:

Purpose of a CAPA system
1. Definitions
21 CFR 820 Quality System Regulation and ISO 13485 CA-
PA requirements 2. Correction, Corrective Action, or Preventive Action?
Differences between corrections, corrective actions, pre-
3. CAPA Procedures 21 CFR 820.100(a)
ventive actions and continuous
4. The CAPA Process
improvement
How a CAPA system is integrated throughout a Quality 5. CAPA and Statistical Analysis
Management System (QMS)
6. Effective CAPA Process
Appropriate data sources, how to analyze, and how to
7. RCA (Root cause analysis)
manage (escalation)
How risk management is used in conjunction with the CA- 8. Systematic Root Cause Analysis (The six Steps)
PA system
9. Root cause analysis tools
How to coordinate and analyze data across various data
10. Root cause elements
sources, with an emphasis on potential
issues 11. Effectiveness Checks
Various investigation tools to identify root cause(s) and
12. CAPA and Risk Management
actions
13. Identify Required Actions
Various methods for verifying and/or validating actions
and the difference between verification 14. Verify and Validate 21 CFR 820.100(a)(4)
and validation of identified actions
15. Management Review 21 CFR 820.100(a)(7)
CAPA plans; how to write good CAPA plans, including re-
16. Link Between Complaints and CAPA
sources and timing of actions; and how
to effectively implement CAPA plans
Effectiveness checks and various methods to achieve ef-
fectiveness checks
FDAs perspective on CAPA systems and compliance ex-
pectations

Who Should Attend?

Quality Engineers, Quality Manager, personnel responsible for the implemen-
tation of CAPA systems; and
CAPA system management.

Informes y reservaciones Desarrolla una pasin por aprender. Si lo haces,

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Anthony J.
Off. 664 3806161

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Ing. Julio Flores
Cell 664-368-6928
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