CAPA Training Presentation

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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 Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training. CAPA (Corrective and Preventive Action) Management Training https://www.tonex.com/training-courses/capa-management-training/

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Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.

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ABOUT THE TRAINING PROGRAM :- Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to address, correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is more probable that problem recurrence will be prevented. DESIGNED FOR :- Managers, Engineers, Supervisor and officers engaged in maintenance operation and engineering activities. OBJECTIVE :- At the end of the training program, participants will be able - To gain a basic understanding of the problem solving and decision-making process and the applicable quality tools that support this process. - To develop specific competencies to use the structured approach to problem solving and decision making and the supporting quality tools. TRAINING PROGRAM COVERAGE :- - Basic knowledge about RCA program. - What are the RCA tools ? - More about Why- Why analysis ? - Videos and case studies on RCA

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A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined. The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management. The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach A risk-based CAPA process is more than prioritization. This presentation includes: -An outline of the CAPA process and proposed risk management activities -Various risk control options that can be integrated with corrective actions -How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016 -And more... Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process

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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". TONEX RCA and CAPA Management Training Format The course is fun and dynamic The training is a blend of hypothesis and practice The hypothetical area is conveyed as intuitive introduction The reasonable area incorporates practicing with genuine precedents, singular/bunch exercises, and hands-on workshops 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 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 Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below. CAPA (Corrective and Preventive Action) Management Training https://www.tonex.com/training-courses/capa-management-training/

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