A medical device company's Quality Management Systems (QMS) is built on the US 21 CFR 820 and/or international standard ISO 13485:2016. A unique way to view and integrate the regulatory requirements is to break down the systems into six lifecycle rings and ensure they overlap to define the space where quality lives.
These system lifecycles include documentation, employees, manufacturing equipment and infrastructure, products, suppliers, and components and materials. These systems’ lifecycles have critical subcomponents (i.e., training, change management, competency, records, obsolescence, etc.) that must be evaluated, managed, and maintained.
Collectively, these systems must interact and communicate with one another to maximize the space where quality lives for a product. QMS has an inherited entropy, a measure of a system's disorder, randomness, or uncertainty. If a system is not well maintained, and the appropriate energy is not put in nor made available, doing useful and quality work diminishes as the system’s entropy rises.
It is the role of quality team members to maintain the effectiveness and efficiency of the organization’s QMS and to ensure that the entropy of a system is kept as low as possible. By accomplishing this, the alignment of the system lifecycle rings is maximized.
This webcast will provide a thorough understanding of critical system lifecycles that must work together to maximize the space quality lives for a product in an organization.
Registration Fees & Deadlines
Learning Objectives
- Upon completion, participants will have a review of the history of ISO 13485:2016.
- Upon completion, participants will learn about system lifecycles from the perspective of ISO13485:2016 and learn about each system’s critical subcomponents and their interconnectivity.
- Upon completion, participants will learn about system lifecycle management to maximize the space where quality lives.
Who Should Attend?
Quality and regulatory affairs personnel who work in companies that must comply with quality management systems.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
Siavash Ghaffari
VP of Quality and Regulatory Affairs, Turner Innovations
Siavash Siv Ghaffari has worked in the biotech industry for over 25 years, with 10 years in medical devices. Siv is the vice president of quality and regulatory affairs for Turner Innovations, a medical devices company specializing in X-rays. Siv has also been the director of Quality for a medical device company developing brain-computer interface and the director of reagent QC for in-vitro diagnostics. His career started in R&D as a molecular biologist at Myriad Genetics. He has also taught fundamentals of quality management systems for a medical device company as an associate instructor at the University of Utah. He holds credentials including Certified Manager of Quality/Operational Excellence (CMQ), Project Management Professional (PMP), RAC-Devices, and Certified Medical Device Lead Auditor.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
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