Professional Certificate Program FAQs
What programs are currently offered?
We currently offer 5 Practitioner Certificate Programs and 1 Leader Certification Program. These programs focus on areas most frequently cited by FDA enforcement action. Proficiency in these key areas will better prepare you and your company for your next FDA inspection, by helping you to manage any existing and potential deficiencies with your current quality system and ensure continuous improvement.
Practitioner Certificate Programs
- Design Control Practitioner
- Management Control Practitioner
- Production and Process Controls Practitioner
- Supplier Management Practitioner
- Quality System Practitioner
Leader Certification Program
What is the difference between the Practitioner Certificate and Leader Certification Programs?
Participants in the Practitioner Certificate Program gain the knowledge and skills to serve as internal subject matter experts. They are able to drive improved performance and compliance in their organizations. To earn a Practitioner Certificate, you must successfully complete each course in your program and pass each course exam. Practitioner Certificates do not expire.
Participants in the Leader Certification Program are recognized as internal subject matter experts in their focus discipline and can lead a team of Practitioners. In addition to completing a set curriculum and passing each course exam, Leader candidates must demonstrate “real-world” proficiency by completing and documenting a discipline-related project. Oriel STAT A MATRIX reviews the Project Report—and conducts an online interview—to verify the candidate’s understanding of the tools taught in the Leader Certification Program.
What do I need to do to get a Practitioner Certificate?
To earn a Practitioner Certificate, you must successfully complete each required course and pass each course exam. Once you complete all requirements, you will receive your Practitioner Certificate.
What do I need to do to get a Leader Certification?
To earn your Leader Certification, you must successfully complete each required course, pass each course exam, complete a capstone project report, and participate in a web-based interview. Once you complete all requirements, the STAT A MATRIX Institute will issue your Leader Certification.
How do I take the required course exams?
Upon successfully completing each course, you will be required to take and pass a course exam. For all Internal and Lead Auditor classes, the exam is administered as part of the classroom training and you must earn a minimum grade of 70%.
For all other courses, the exam will be administered electronically, after you complete the course. To pass the class, you must take the exam within 30 days of completing the class and earn a minimum grade of 70%. If you fail the exam, you may retake it once within 1 year of completing the course.
Does my Practitioner Certificate or Leader Certification expire?
Your Practitioner Certificate will not expire, and you will not need to renew it.
Leader Certifications are valid for 3 years upon successful completion of the project. After that, candidates must be recertified in the specific discipline by completing the recertification curriculum. In order to renew a certification, a candidate will be required to submit evidence of a relevant project to Oriel STAT A MATRIX, so that we can verify that the candidate is still able to effectively apply the skills and knowledge attained during the Certification Program. The project the candidate submits for recertification must be one for which the candidate was personally responsible for over the previous 18 months, or one on which the candidate served as a member of the project team.
What is the STAT A MATRIX Institute?
Your certificate will be issued by the STAT A MATRIX Institute, a not-for-profit educational institute formed in 1974. The STAT A MATRIX Institute provided training to the FDA investigators in 1977, when the agency developed the Medical Device Good Manufacturing Practices (GMP). Since then, we have provided regulatory and compliance training to tens of thousands of RA and QA professionals.
How much does the Program cost?
For both the Practitioner Certificate and Leader Certification programs, you will pay individual course fees (tuition) for each course. The total cost will vary depending on when you register and the availability of any course discounts.
There is no additional charge to earn your Practitioner Certificate beyond the course fees.
To attain Leader Certification, there is an additional cost of $1,500 that is related to overseeing your required project. This cost is payable prior to your web-based interview. A similar fee will apply when you go through the recertification process.
Do I need to complete the required courses in a certain period of time?
Yes. We require students to complete the courses within a 3-year period because we update our courses regularly to reflect changes in the industry.
If I took one of the required courses in the past, can I take the exam and have that course count toward a program?
For non-auditor courses, if you took the course in the past 3 years, you can ask to take the online exam and “place out” of that course requirement. Contact us so we can create an individualized plan for you.
For our Lead, Internal and Advanced Auditor classes, if you have completed the course and successfully passed the exam within the past 3 years, there is no need to take another exam and the course will count toward your program.
How do I get started?
First, contact us and tell us you want to pursue a program. We will formally enter you as a candidate for your selected program. There is no cost to declare your intention and no obligation to enroll in any courses.
When you are ready to start your training, you can select a specific course from orielstat.com/training and register for a session of your choice. All of the courses that are part of our Practitioner Certificate and Leader Certification programs are offered as open-enrollment classes. They run multiple times per year in cities across the US. Sign up for each course individually, using a pay-as-you-go model. Upcoming course dates and locations can be found here.
