Course Overview
Validation for Medical Device (IQ, OQ, PQ)
“Quality is generally transparent when present, but easily recognized in its absence.” — Alan Gillies
This course provides the participants with the knowledge and skills to conduct validation for medical devices. This validation knowledge also can be applied in accordance with ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems.
How You Will Benefit
Making sure that you have objective evidence that user needs and intended uses are met.
Increased usability and reliability, decreased failure rate and recalls, and reduced risks to patients and users.
Course Objectives
Familiarize with the latest FDA guidelines and interpretations of product/process validation.
Recognize how Validation Master Plans help the planning process.
Differentiate between qualification, verification and validation.
Identify if (and when) validations are required.
Determine what activities must be completed prior to conducting a validation (confirming) event.
Learn how to conduct and document a validation event.
Understand what to do when things go wrong (What if’s!).
Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.
Who Should Attend
Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices. Professionals directly involved in meeting the FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development or manufacturing.
Our Solutions
This course can be run in-company around the world.
We can tailor the content to focus on your requirements.
This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback.
Delegate manuals and certificates of Attendance will be provided.
Course Content
Introduction
Process Validation — The FDA Quality Systems Regulation (QSR)
The Process Validation Model
Validation Components
Validation Master Plans
Installation Qualification (IQ)
Operational Qualification (OQ)
Validation Tools
Sample size determination
Performance Qualification (PQ)
Monitoring
Revalidation
Numerous team exercises
