CAPA Management Training from Tonex. CAPA stands for Corrective And Preventive Action. An important part of RCA ( Root cause analysis ) .
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field.
As you may know, it is crucial in clinical trials to identify the noncompliance, correct them, and inhibit them from happening again in future. Root cause analysis methods allow you to dig down to the bottom of the problem, identify the underlying causes, and change/eliminate them.
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. Such efficient CAPA process can significantly help you enhance preventing the human-errors and confidence in the truthfulness of the data.
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
The definition and differences of the terms corrections, corrective actions, and preventive actions
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
Problem solving tools, Process mapping, Regulatory resources
Corrective action plan development steps
Defining the problem statement properly
Isolating and containing the problems, Identifying the root cause
Developing an effective corrective action
Executing and validating the corrective action
Preventing recurrence, Preventive Action process
And more.
How Can You Benefit from this Training?
Learn how to collect & analyze information to identify actual, potential product & quality problems
Investigate product and quality problems and take appropriate and effective corrective or preventive action
Verify or validate the effectiveness of corrective and preventive actions
Learn root cause analysis to see underneath the complication of pharmaceutical and bio-pharmaceutical manufacturing, securely answer warning letters, please auditors, and inhibit future issues
Set up an organized technique to categorize and prioritize studies, explore the real cause, select the most effective and efficient corrective and preventive actions to secure compliance and enhance output
Shorten the cycle time for study approval and the frequency of open investigations.
Integrate risk analysis into decision making to inhibit the same problems from happening again in future and empower the chances of improvement
Utilize rational and data to analytically explore and approve real root causes
Decrease the investigations costs by improving the CAPAs (in efficiency and timing)
Apply insightful questioning approaches
Improve your thinking method and communication skills.
Avoid FDA 483s warning letters
Improve your internal audits
Speed up the reviews/approvals
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
Guarantee satisfactory site issues management
Apply the suitable models based on the nature of the root cause analysis process
Implement performance management notions
Understand deeply the elements of effective Corrective Action planning and documentation
Discuss successful Preventive Action planning and implementation
Improve their current CAPA system
Increasing their confidence with FDA audits
Recognize effective corrections, corrective actions and preventive actions, resulting in saving time and resources.
Course Outline (Can be Customized with Optional Module):
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
Learn more. Request more information. Visit Tonex training website link below
CAPA (Corrective and Preventive Action) Management Training
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