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CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.

Learn About:

CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...

TONEX RCA and CAPA Management Training Format:

The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops

Audience:
CAPA Management is a 4-day course designed for:

CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.

Training Objectives:

CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...

Course Outline:

Overview of CAPA
#RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample

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#CAPA (Corrective and Preventive Action) Management Training
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