ISO 13485 - IQOQPQ - Process Validation for Medical Devices
What you'll learn
- Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations.
- In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility
- Create a Process Validation Procedure
- Perform Installation Qualifications
- Perform Operational Qualifications
- Perform Performance Qualifications and launch your New product Introductions regime
- Plan your New Product Introductions (NPIs)
- Teach IQ OQ PQ to your teams and collaborate better
- Molding Qualification
- Injection Molding Process Validation
Requirements
- Basic knowledge of Quality inspection will help
Description
Process Validation of Class 1/2/3 Medical Devices shall meet ISO 13485 standard and FDA 21CFR 820.75 requirements.
The objective of the course is to provide the course audience with the tools and knowledge to use the Process development, Quality principles and Program management to perform their Process Validation activities to meet regulatory, compliance and customer requirements.
It is a vast subject based on your products, medical device class, team size, manufacturing method etc.
The course is explained with various phases and links to make a New Product Launch Validation successful.
A Designer doesn't get a manufacturing perspective, a Process Engineer doesn't understand a QE and QC lab perspective, the Instructor covered all those important bases to make this course holistic to manage and be successful.
This course will teach you cross collaboration activities involved in Process Validations from Engineering responsibility to Quality to Operations.
This is a high collaboration work with various hand offs between various functions in your organization, but once trained on the overall process, you will be ready to start. The first 2 product launches will help you identify the processes and the bottlenecks within, and when you are ready to launch your third product, your team's maturity on the process will help a lot to successfully & smoothly do your Process Validation.
The standards and FDA requirements have a lot of room for interpretation, the Instructor has taken his best diligence to provide guidance through this course. At the end of this course, you will have been provided with an overview of the Process Validation regulatory requirements and what you need to perform them without any bottlenecks in your organization.
A very good luck on this journey.
Who this course is for:
- Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians
- Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters
- Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers
Course content
- Preview09:44
- 07:14483s - Data Analysis
- 04:46Manufacturing Scenario
- 6 questionsQuiz 1
Instructor
![Phaniendra Somraj](data:image/svg+xml,%3Csvg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 64 64"%3E%3C/svg%3E){kind=avatar}
- 4.0 Instructor Rating
- 12 Reviews
- 41 Students
- 1 Course
Phaniendra Somraj has held a variety of leadership roles in the Medical Device, Aerospace, Micro-Irrigation, Automotive industries as well as Consulting Services. He has global experience in his tenure leading global teams in countries like US, Italy, Romania, China and Australia. He has expertise in Lean Six Sigma principles completing successful Black Belt projects and has written a book to document a "Scientific & Simple Problem Solving Framework (SSPSF)" for problem solving in Enterprises.
He has in-depth knowledge in ISO 13485 and QSR regulations in addition to CAPA program, Internal Auditing, Continuous Improvement (Kaizen) projects, Validations and Verifications (IQ OQ PQ), 21 CFR Part 11, ISO 9001, ISO 14644, ISO 14971, Customer incident investigations, Root cause analysis, Value Stream mapping etc.
Education:
MS in Mechanical Engineering, University of Michigan, Ann Arbor | ME in Advanced Manufacturing Technology, University of South Australia, Adelaide | Bachelor of Technology in Mechanical Engineering, JNTU, India.
Certifications:
ISO 13485 2016 Lead Auditor | Master Black Belt in Lean Six Sigma | Certified Scrum Master | CMMI 2.0 Associate | Quality Process Analyst | Enterprise Design Thinking Practitioner | Tableau 10.0
His research "Design of a Bistable Compliant Locking Mechanism for New generation Mirror Actuator" from Centre for Advanced Manufacturing Research, University of South Australia, South Australia was published in 2005 ASME Florida conference
Authored a Book: Continuously Improve to Continuously Innovate: Journey to Innovate through Lean principles and Scientific & Simple Problem Solving Framework (SSPSF)
Speaker, Lean Six Sigma World Conference 2021, Florida, USA