Process Validation for Medical Devices
With this training course, you will:
- Be qualified to carry out standard-compliant validations for the manufacturing process of medical devices.
- Acquire know-how for an efficient validation process, also in relation to change management.
- Know the conditions and limitations of applying risk-based validation methods.
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?
Employees and persons involved in the validation of manufacturing processes, such as:
- Quality management (QM) specialists
- Developers
- Project managers
- Executives with responsibility in validation
- Consultants
- Service provider for validations
Course Agenda
DAY 1: OVERVIEW
- Basics of process validation
- Overview of the current standards: ISO 13485:2016 and FDA CFR 21 Part 820
- Terminology (IQ, OQ, PQ)
- Validation planning
- Risk-based statistical sampling plans based on RQL and AQL
- Documentation
- Change Management
DAY 2: WORKSHOP
- Preparation of a validation plan based on an example from the field of non-active medical devices
- Examples of IQ- and OQ-protocols and important conditions for implementation (documentation, measurements, traceability)
- Integration of risk management according to ISO 14971
- Summary and validation reports
Course Description
Ensuring quality by final inspections and tests alone is not sufficient due to complexity of medical devices. The instrument of process validation proves that manufacturing processes are developed safely and work reliably over the entire duration of the product life. Based on clear terminology and practical examples, the seminar gives you the necessary expertise to carry out and design a process validation. Thereby, relevant requirements from ISO 13485:2016, FDA CFR 21 Part 820 and the Medical Device Single Audit Program (MDSAP) will be used and explained. In addition, key elements of the statistical sampling plan design for validated processes are explained and integrated into the validation planning by means of a risk-based overall approach.
Methodology
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.
Prerequisites
No requirements are necessary.