CAPA Management Training
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in medical field.
What is CAPA?
CAPA, standing for Corrective Action and Preventive Action, refers to the modifications and improvements need to be done in an organization’s processes in order to remove causes of non-conformities and deviations of the system.
CAPA essentially belongs to good manufacturing practice (GMP). It emphasizes on the organized studies of the underlying causes of a targeted problem or the real reason of an accident. CAPA will help change/eliminate the causes (corrective action) and also to inhibit them from happening again (preventive action).
Usually, when there are complaints from customers, some nonconformance are detected, corrective actions are implemented in response to customer complaints, issues determined during an internal audit, or unstable trends in product are monitored, then corrective action plans are implemented. Preventive actions are also executed in response to the detection of potential sources of non-conformity.
It is crucial to make sure the implemented CAPA is effective. Therefore, a regular investigation of the root causes of failure is vital.
CAPA Objectives
- Collect and analyze information
- Identify and investigate the current and potential product and quality problems in the future
- Take appropriate, effective, and comprehensive corrective and/or preventive actions
Added Value of CAPA Training
- Definition of CAPA?
- Where CAPA is applied
- CAPA best practices
- FDA’s requirements for CAPA systems
- Why having CAPA in place matters?
- CAPA system elements
- CAPA data resources and tools
- Monitoring and criticizing CAPA
- How to make sure the implemented CAPA is effective
- FDA guidance for FMEA
- FDA’s trending principals
- ECI
- Non-conformances or deviations
- Regulatory resources
Audience
CAPA Management training 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.
What Will You Learn?
Below are the major topics covered by CAPA management training (more details can be found HERE):
- Overview
- 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
CAPA Management Training