Design Control Practitioner Certificate
Design Control is one of four major areas of the FDA’s Quality System Inspection Technique (QSIT) and it is covered during every FDA inspection. In fact, Design Control constitutes about a quarter of what the FDA evaluates during a site inspection, and it is the most frequently cited quality system deficiency. Approximately 44% of device recalls are due to faulty design.
About the Design Control Practitioner Certificate Program
As a Design Control Practitioner, you'll gain a deep understanding of the process management and problem-solving skills that medical device companies need to control the entire design process. Design Controls Practitioners are able to recognize and mitigate serious Design Control issues, assess risk, and ensure that Design Control is effectively integrated in the company’s Risk Management and Design Control processes.
Training Course Requirements
To earn your certificate, you must complete the following 4 courses and pass each course examination. You will have up to 36 months to meet these requirements.
- Implementing Design Control Requirements and Best Practices – 3 Days
- Risk Management and Analysis for Medical Devices – 2 Days
- Complaint-Handling and Recall Management: Maintaining a Compliant Program – 3 Days
- Global Product Submissions: FDA and EU Directive Requirements [510(k), PMA, CE Mark] – 3 Days
Who is this program intended for?
While this program will be of interest to anyone involved in Medical Device RA/QA, it may appeal most to individuals involved in the following areas: R&D, Product Development, Regulatory Affairs, Quality Assurance, Clinical Affairs, Manufacturing, and Internal Auditing.
If I took one of the required courses in the past, can I take the exam and have that course count toward a program certificate?
For non-auditor courses, if you took the course in the past 3 years, you can request to take the online exam and “place out” of that course requirement. For our Lead, Internal and Advanced Auditor classes, if you have completed the course and successfully passed the exam within the past 3 years, you do not need to take another exam and the course will count toward your program certificate.
How do I sign up?
First, contact us and tell us you want to pursue certification. We will formerly enter you as a candidate for your selected program.
When you are ready to start your training, select a specific course from the links above or at orielstat.com/training and register for a session of your choice. They run multiple times per year in cities across the US. Sign up for each course individually, using a pay-as-you go model. Alternatively, if you have 6 or more employees who would benefit from this program, we can offer the complete program on-site at your facility. Contact us for more information about the on-site option.
