Corrective and Preventive Actions (CAPA) in the field of Medical Devices
This course is certified by Exemplar Global.
Master Effective CAPA Strategies: Understanding Data, Finding Root Causes, and Effectively Eliminating
Manufacturers of medical devices often collect large amounts of data but struggle to understand and derive effective measures from it. Current regulations such as ISO 13485:2016, 21 CFR 820 (FDA), and EU 2017/745 (MDR) require robust systems for data analysis, root cause analysis, and CAPA. This seminar will guide you on which data to collect and how to analyze it. Through practical exercises, you will learn basic methods for data analysis and root cause analysis and understand the key requirements in the area of CAPA. Practical examples will be presented to help you apply these strategies in your day-to-day operations.
By participating in this training course, you will:
- Analyze Data Effectively: Learn which data needs to be analyzed and how to use the appropriate tools.
- Identify Root Causes: Understand how to identify underlying causes in a targeted manner.
- Master CAPA Terminology: Gain knowledge of basic CAPA terminology and see examples of its application.
Join us for this essential 1-day training course to enhance your understanding of CAPA and ensure your organization meets the highest standards of quality and compliance. Enroll today and take the first step towards mastering effective CAPA strategies for medical devices!
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Who Should Attend?
This course is ideal for professionals involved in the product realization of medical devices, including:
- Quality Management (QM) Specialists
- Post-Market Surveillance (PMS) Experts
- Process Developers and Product Developers
- Regulatory Affairs Professionals
- Managers with Responsibility for Quality or Production
Course Agenda
Course Contents at a Glance
- Differences Between Correction, Corrective Action, and Preventive Action: Understand the distinctions and applications.
- Requirements for Data Analysis: Learn the requirements from ISO 13485:2016, 21 CFR 820 (FDA), and EU 2017/745 (MDR).
- Methods and Tools for Data Analysis: Engage in practical exercises in small groups to learn data analysis and problem definition.
- Risk-Based Escalation: Understand how to escalate issues based on risk.
- Requirements for Corrective and Preventive Measures: Learn the basics from ISO 13485:2016.
- Components of a CAPA System: Understand the essential components.
- Methods and Tools for Root Cause Analysis: Participate in practical exercises to learn root cause analysis.
- Action Planning, Implementation, and Effectiveness: Learn how to plan, implement, and ensure the effectiveness of actions.
- Documentation and Reporting: Understand the expectations for documentation and reporting.
- Interfaces to Other QMS Processes: Learn how CAPA interfaces with other quality management system processes such as PMS, risk management, and management review.
Course Description
Enhance your quality management skills by mastering Corrective and Preventive Actions (CAPA) in the field of medical devices. Our 1-day training course, certified by Exemplar Global, is designed to help you understand data, find root causes, and effectively eliminate issues to ensure compliance with current regulations.
Benefits
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation todayMethodology
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognized TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Learning Assessments
Certificate of attendance from TÜV SÜD Academy.
Prerequisites
No prerequisites or prequalifications necessary.