PROCESS VALIDATION FOR MEDICAL DEVICES
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - Nov 2024
Master process validation and ensure top-quality medical device manufacturing with this interactive, self-paced course.
- Grasp the importance of performing process validation, when it is necessary and/or beneficial, and how to execute it effectively.
- Learn key validation techniques and avoid common pitfalls.
- Understand regulatory requirements, standards, and guidelines for process validation.
- Identify which processes need validation and how to maintain a validated state.
- Plan, perform, and revalidate processes using historical data within a quality management system.
Select your course plan
ONLINE
YOU ARE HERE
€ 349
Launch discount until Oct 31, 2024
Average completion time 4-12 hours
Total video duration 2.5 hours
CPD points 8
Number of quizzes 19
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
ONLINE LIFETIME
€ 449
Launch discount until Oct 31, 2024
Average completion time 4-12 hours
Total video duration 2.5 hours
CPD points8
Number of quizzes 19
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Templates
Course overview
This online course focuses on understanding process validation for medical devices. In this course, you will learn the importance of performing process validation, when it is necessary and/or beneficial, and how to execute it effectively. It also covers regulatory requirements for process validation, as well as applicable standards and guidelines.
The course is specifically designed for those who are involved in product development, design transfer, and manufacturing of medical devices, as well as quality assurance personnel.
Topics covered include: a process validation overview, the applicable regulatory framework, when and how to perform process validation, how to maintain a validated state, revalidation, and the use of historical data.
The online course is made up of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate upon successful completion of the course. There is also a downloadable course companion within the course.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
Course modules
- Welcome
- What you need to know
- Set your course completion date
- Pre-course assessment
- What is process validation and why it is important
- The regulatory framework
- Overview of the process
- When to perform process validation
- Process validation candidates
- ISO 80002-2 validation of software for medical device quality systems
- Who should be involved
- A risk based approach
- Master validation plan
- User requirement specification and validation planning
- Installation qualification – Part 1
- Installation qualification – Part 2
- Operational qualification – Part 1
- Operational qualification – Part 2
- Performance qualification
- Final report and master validation report
- Summary – Process validation documentation
- Maintaining a validated status
- Use of historical data
- Pre-final exam
- Final exam
- Course evaluation
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
Benefits for you
Understand why and how to do process validation
Process validation is a critical component of designing and manufacturing medical devices. It acts as a proactive measure to identifying potential issues before products are released to the market. By performing process validation on necessary processes, you ensure the products you release are of high quality, which results in safer products and more satisfied customers and users. Additionally, process validation can help manufacturers lower production costs.
By the end of this course, you will be able to determine when to perform process validation, understand how to perform it, and learn how to maintain your processes in a validated state.
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information.
This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Training effectiveness and record-keeping
Participants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness.
Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability.
Helena Hjälmefjord has extensive experience within the medical device industry, Class I to Class III devices, and In-Vitro diagnostics; as well as with allografts (human tissue). Amongst others, she has worked as project leader, quality manager as well as design control and regulatory assurance lead. Helena has worked in both small companies as well as large international companies. Since 2014 she works through her own consultant company, Fjord Consulting.
Helena’s motivation is getting customers to understand the importance and benefits of the regulations that are placed on their medical device products and related processes.
Frequently asked questions
All in all, the average time to complete the course is 4-12 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.
If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
The instructor possesses over 20 years of hands-on experience in the medical device industry, having worked extensively in design and development, quality management, and regulatory affairs. She is also the founder and CEO of a medical device consulting firm.
Reviews
Group purchase
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.