Process Validation for Medical Devices
Validating the manufacturing process efficiently and in compliance with standards – prerequisites and possibilities
Ensuring consistent product quality in medical device manufacturing requires more than random inspections or end‑of‑line testing. Because many devices and their production processes are highly complex, manufacturers must demonstrate that their processes are safe, stable, and capable throughout the entire product life cycle. This training provides the essential knowledge and practical tools you need to achieve exactly that.
In this course, you will learn how equipment qualification and process validation work together to confirm that manufacturing processes are properly designed, controlled, and continuously reliable. Using clear terminology, real‑world examples, and hands‑on guidance, the course builds your expertise in planning and executing robust validations.
All key regulatory foundations are covered in detail, including ISO 13485:2016, FDA 21 CFR 820 (QMSR), and the Medical Device Single Audit Program (MDSAP). You will also learn how to design sampling plans for validated processes and how to integrate them into a risk‑based validation strategy.
By the end of the training, you will confidently understand and apply the core elements of IQ, OQ, and PQ—and be equipped to implement validation requirements effectively within your organization and across outsourced manufacturing partners.
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].
Persons involved in the validation of manufacturing processes, such as:
- Quality Management (QM) specialists
- Process Technicians and Engineers
- Process and Product Developer
- Project Managers
- Managers with Validation Responsibilities
- Consultants and auditors
- Service providers and suppliers
- Basics and terms of process validation
- Overview of the current state of regulation (ISO 13485, 21 CFR 820, MDSAP)
- Installation Qualification (IQ) with Computer System Validation
- Functional Qualification (OQ) and Performance Qualification (PQ)
- Validation Planning
- Risk-based sampling plans based on RQL and AQL
- Change control and monitoring of validated processes
- Implementation-oriented workshop:
- Creation of a concrete validation plan and an OQ based on an example from the field of non-active medical devices
- Documentation Practices
- Gain a solid understanding of internationally recognized standards—making this training fully applicable for global operations and teams.
- Learn up‑to‑date, standards‑compliant methods for conducting equipment qualification and process validation in medical device manufacturing.
- Develop practical know‑how to design and execute efficient validation activities both within your organization and across your supply chain.
- Understand the requirements, prerequisites, and practical use of risk‑based approaches to process validation—enabling smarter, compliance‑driven decision‑making.
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.
This single training addresses internationally valid standards. The contents of the training correspond to the current status of the revision/harmonization.
Certificate of participation from the TÜV SÜD Academy
No requirements are necessary.