Price: $3,999.00
Length: 4 Days
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CAPA Management Training

CAPA Management Training Course Description

CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field.

CAPA Management Training

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. Otherwise, absence of an effective corrective action management in place can result in frequent non-compliance, unreliable subject safety, poor data quality, and/ or improper investigation outcomes followed by drastically harmful effects on the final submission. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course emphasizes on how to effectively manage the noncompliance problems happening at research spots. All stakeholders in clinical research including the sponsor, CRO, investigator/site, and IRB/IEC can benefit from this hands-on training course.

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
  • Communication

How Can You Benefit from this Training?

  • Learn how to collect and analyze information to identify actual and potential product and 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 FDAhttp://www.fda.gov 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
  • Understand the language of regulators once they describe non-conformities
  • Determine the useful CAPA data sources and collect effective feedback
  • Choose and use appropriate CAPA tools to resolve quality issues
  • Execute a proper failure investigation and accurately identify root causes
  • Use relevant statistic tools to find and fix the issues with CAPA

Course Outline (Can be Customized with Optional Module)

Overview of CAPA

  • What is CAPA?
  • Principles behind Corrective and Preventive Action (CAPA)
  • CAPA definition
  • Corrective action and preventive action
  • The purpose of the corrective and preventive action
  • Analytical vs creative thinking
  • Content vs process thinking
  • Investigator Noncompliance definition
  • Regulatory definitions and categories
  • FDA’s requirements for CAPA systems
  • FDA guidance for failure investigations and root cause analyses
  • FDA’s trending principals
  • Performance Management Concepts

RCA Definition

  • RCA importance
  • CA Definition of RCA
  • Origin and evolution of RCA
  • Applications of RCA
  • Benefits and limitations of RCA
  • RCA and CAPA application in pharmaceutical, clinical manufacturing, biologics and medical device industries
  • Data gathering methods

Non-Conformances or Deviations

  • What is nonconformance or deviation?
  • Nonconformance types
    • Methods
    • Manpower
    • Material
    • Machineries
    • Environment
  • Who is responsible for reporting a nonconformance?
  • Regulatory agencies
  • cGMP compliance
  • GDP requirements
  • Nonconformance exceptions
  • When is Regulatory Affairs Approval Required?
  • Standard non-conformance process
  • Standard deviations process

Nonconformance Classification

  • Minor NC
    • Low or No Risk of product impact to SISPQ
    • No immediately impact or requires minimal evaluation
    • Probability of future detection is HIGH
    • Controls and testing in place to detect this event
    • No probability of impact to Quality of subsequent lots
  • Major NC
    • Moderate Risk of product impact to SISPQ
    • Product impact requires additional testing and is not immediately known
    • Probability of future detection is MODERATE – HIGH
    • Controls and testing in place to detect this event, but did not catch it
    • Low – Medium probability of impact to Quality of subsequent lots
  • Critical NC
    • High Risk of product impact to SISPQ
    • Product impact requires additional testing and is not immediately known
    • Probability of future detection is LOW
    • Controls and testing in place to detect this event, but did not catch it
    • High probability of impact to Quality of subsequent lots

Problem Solving Process

  • Discovering the problem
  • Defining problems
  • Studying the situation
  • Collecting the required data
  • Determining solutions requirements
  • Generating creative solutions
    • Brainstorming
    • Reverse Brainstorming
    • Imagineering
    • SCAMMPERR
    • Mind Mapping
    • De Bono’s  6 Thinking Hats.
  • Evaluating the alternatives
  • Selecting the best solution
  • Implementing the solution
  • Developing CAPA
    • Create an action plan
    • Break solution into action steps
    • Prioritize actions and assign roles
    • Follow-up at milestones
  • Monitoring the effectiveness of CAPA
  • Fixing and changing the issues of the implemented CAPA

Creative Thinking Approaches

  • Definition of creativity
  • Definition of creative thinking
  • How do these techniques work?
  • How can creative thinking generate new ideas?
  • How to use creative thinking in brainstorming sessions
  • Advanced tools of creative thinking
    • Computer-based methods
    • Manual methods
  • Create creative environment

FMEA Application in Clinical Devices

  • Failure definition
  • Failure modes classification
    • Complete failure
    • Partial failure
    • Intermittent failure,
    • Function out of specification
    • Unintended function
  • Potential failure modes
  • Potential causes of failure
  • The effects of the causes
  • Failure mode ID
  • Assembly, sub-assembly, parts
  • Failure description
  • Alarming signs
  • Techniques of failure detection
  • All potential effects on assembly and on complete product
  • Failure modes exercise

Analysis and Prioritization Techniques

  • Analysis models
  • Systematic techniques to problem solving
    • Methods of analysis
    • Gathering relevant information
    • Stating the limitations and restrictions
    • Applying stair-step method to break down complex problems
  • Decision analysis
    • Selecting the best among all the alternatives
    • Establishing the objectives
    • Associating weight to each objective to make the best decision
    • Coming up with a pleasure metric to decide among options

Digging Down for the Root Causes

  • Main objectives and phases of effective failure investigations
  • How to execute a proper failure investigation to its root cause
  • 00S (Out-of-Spec) investigations
  • Five ways to identify potential causes
  • Detailed examination of Gilbert’s Behavioral Engineering Model and its application to root cause analysis
  • Behavioral interviewing
  • Effective, open-ended questioning
  • Three ways to choose or remove causes
  • Fault tree analysis
  • Cause and effect diagrams
  • Tools for Problem Cause Brainstorming
    • Problem Cause Brainstorming
    • The Purpose and Application of Brainstorming
    • Brainstorming Recording Templates
  • Principals of brainstorming
  • Brainstorming components
  • How to conduct a brainstorm session
  • Brainstorming tools
  • Fishbone diagram

Gathering Valuable Data for RCA and CAPA

  • Problem cause data gathering
  • Historical records
  • Operations records
  • Steps in using samplings
  • Population vs sampling
  • Use check sheets, graphs, and tables
  • Advantages of surveys, interviews, and field observation for opinions
  • Problem cause data collection checklist

Analyzing Data

  • Understanding problem cause data analysis
  • Tools for data analysis
    • Run charts
    • Histograms
    • Pareto diagram
    • Modified scatter diagram
    • Pivot tables
    • Affinity diagrams
    • Relationship diagrams
  • Integrative data analysis tools

Accidents Analysis and Role of Human Error

  • Various incident/accident analysis
  • Human error, causes and solutions

Role of Management Behaviors in the Success of RCA/CAPA

  • RCA affected by the cognitive biases
  • Organizational culture effects
  • Supportive roles
  • Application of Performance Management Concepts
  • 7 comprehensive compliance management steps

Implementing Corrective and Preventive Action Plans (CAPA)

  • CAPA data gathering tools
  • Organizing the solutions implementation
  • Deriving an action plan
  • Use tree diagrams
  • Develop change acceptance
  • Force-Field analysis
  • Problem solving and implementing both short-term corrective and long-term preventive actions
  • Review and criticize simulated monitoring reports documenting noncompliance and CAPA

Elements of Effective CAPA

  • Structure of an effective CAPA
  • Definitions of a correction, corrective action, and preventive action
  • How do you organize your CAPA and if it’s effective?

Trending Requirements and CAPA

  • Drug and device trending requirements
  • How to apply proper statistics to discover and fix CAPA problems
  • Often dismissed but crucial sources of internal and external feedback
  • Use of Risk (Process, Product) to identify when and if to escalate an observation to a CAPA

CAPA Regulatory Requirements

  • FDA’s requirements for CAPA
  • Specific GLP, Drug GMP, and Medical Device CAPA regulations
  • Why CAPA matters to FDA
  • Role of CAPA in meeting international rules and standards

TONEX RCA and CAPA Hands-On Workshop Sample

  • Providing real-world scenarios and case-studies to practice each of the performance management concepts
  • Individual and group activities to perform based on a real example of FDA warning letters
  • Determining all the noncompliance in the case-studies
  • Problem solving methods
  • Methods for collecting  and analyzing information
  • Identify and investigate product and quality problems
  • Taking appropriate and effective corrective and/or preventive action to prevent  recurrence
  • Verifying or validating corrective and preventive actions
  • Communicating corrective and preventive action activities to responsible people
  • Providing relevant information for management review
  • Preparing surveys and questioners to gather data for the RCA investigation
  • Identifying the real causes associated with the targeted problem
  • Brainstorming all the possible solutions
  • Choosing the best solution
  • Developing a corrective actions plan
  • Developing a preventive actions plan
  • Documenting the issue in monitoring reports and correspondence
  • Presenting the RCA process and CAPA to the class
  • Discussing the problems and strengths of each CAPA

CAPA Management Training

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