Medical Device Process Validation. ISO 13485. IQ OQ PQ
5.0 /5- Offered byUDEMY
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Overview
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
Validate a process to gain approval to sell medical devices in the EU, U.S. & Internationally. Compliance to ISO 13485
Duration | 2 hours |
Total fee | ₹455 |
Mode of learning | Online |
Credential | Certificate |
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Highlights
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
- Earn a Certificate of completion from Udemy
- Learn from 11 downloadable resources & 1 article
- Comes with 30 days money back guarantee and full lifetime access
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Course details
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
Skills you will learn
Who should do this course?
- For Production Managers
- For Supervisors
- For Technicans
- For Manufacturing Engineers
- For Process Engineers
- For Quality Engineers
What are the course deliverables?
- Understand what Process Validation means for any industry
- Understand the three types of validation
- Learn what design qualification means
- Learn what a performance qualification (PQ) is
- Learn what user requirement specification (URS) means
More about this course
- The course focuses on medical device process validation
- Explain the regulation governing process validation within the medical device industry
- This will explain how ISO 13485, the FDA Quality system regulation (QSR) and the FDA 21 CFR 820 fit into regulation that governs process validation
- Install qualification will be explained which contains the factory acceptance test and the site acceptance test
- Understand the Design of experiments and how this is used in the operational qualification part of process validation
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Curriculum
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
Introduction
Lecture 1 What is Process Validation, why we need it and what is verification
Lecture 2 Introduction to Process Validation
Lecture 3 Decision steps to validate a process
Lecture 4 Medical Device Regulation within Process Validation
Lecture 5 Different Types of Process Validation
Process Validation
Lecture 6 User Requirement Specification
Lecture 7 Design qualification
Lecture 8 Installation Qualification
Lecture 9 Factory Acceptance Test
Lecture 10 Site Acceptance Test
Process Capability
Process Capability Part 1 Validation
Process Capability Part 2 Validation
Process Capability Part 3 Validation
Risk Management
Process validation Risk Management
Process Validation Documentation
Process Validation Documentation
Validation Master Plan Process Validation
Validation Plan
Validation Change Control
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Faculty details
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
Martin Conneely
Martin Conneely has been over 20 years experience working in high volume manufacturing. He has worked in the semiconductor business for 10 years. He worked in the life science industry in particular the medical device industry. He has worked for European and America companies in these sectors.
Other courses offered by UDEMY
₹599
10 hours
– / –
View Other 2351 Courses
Medical Device Process Validation. ISO 13485. IQ OQ PQ at UDEMY Students Ratings & Reviews
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
5/5
5 Ratings- 4-55
A
Altaf Amsari
Medical Device Process Validation. ISO 13485. IQ OQ PQ
Offered by UDEMY
5
Learning Experience: Awesome
Faculty: Great
Brilliant
Course Support: Grand
Reviewed on 16 Mar 2023Read More
S
Shashank Rajendra Tiwari
Medical Device Process Validation. ISO 13485. IQ OQ PQ
Offered by UDEMY
5
Learning Experience: The course was really great and it would really help to understand ISO 13485
Faculty: Faculty was really great and the quality of knowledge they provide is great
Course resources are really good and it is in structural manner
Course Support: Helped me to understand Life Science domain
Reviewed on 10 Dec 2022Read More
G
Gangavaram Jaswanth
Medical Device Process Validation. ISO 13485. IQ OQ PQ
Offered by UDEMY
5
Learning Experience: Process Validation, IQ, OQ, PQ, FAT, SAT, MASTER VALIDATION PLAN, DESIGN OF EXPERIMENTS AND PROCESS CAPABILITY AND RISK MANAGEMENT.
Faculty: Instructors taught well
Curriculum was relevant and comprehensive
Course Support: Career support was helpful
Reviewed on 22 Mar 2022Read More
V
VENKADESH S
Medical Device Process Validation. ISO 13485. IQ OQ PQ
Offered by UDEMY
5
Learning Experience: Iso13485 validate especially medical device manufacturing unit.
Faculty: Instructors taught well
Curriculum was relevant and comprehensive
Course Support: No career support provided
Reviewed on 26 Feb 2022Read More
S
Subhadeep Mukherjee
Medical Device Process Validation. ISO 13485. IQ OQ PQ
Offered by UDEMY
5
Other: Learnt few information
Reviewed on 4 Oct 2021Read More
View All 5 Reviews
Medical Device Process Validation. ISO 13485. IQ OQ PQ
at UDEMY
Student Forum
Anything you would want to ask experts?