Management Control Practitioner Certificate
Management Control Practitioners reinforce your company’s Quality System policies and objectives – a critical role for compliance AND company success.
Management Control is one of four major areas of the FDA’s Quality System Inspection Technique (QSIT) and it is covered during every FDA inspection. Deficiencies related to Management Control are among the most frequently cited quality system issues experienced by companies.
About the Management Control Practitioner Certificate Program
Geared toward Medical Device RA/QA professionals in positions of leadership, Management Control Practitioners learn the skills and knowledge necessary to:
- Establish and maintain a Quality System that is appropriate for the specific device their company designs and produces
- Recognize, mitigate, and improve any existing deficiencies with their organization’s current Quality System
- Ensure that adequate resources and proper controls are in place
Training Course Requirements
To earn your certificate, you must complete the following 5 courses and pass each course examination. You will have up to 36 months to meet these requirements.
- Quality Systems for Medical Devices: FDA’s QSR and ISO 13485 – 3 Days
- Global Product Submissions: FDA and EU Directive Requirements [510(k), PMA, CE Mark] – 3 Days
- Complaint-Handling and Recall Management: Maintaining a Compliant Program – 3 Days
- Developing and Maintaining a Compliance Document Management System – 2 Days
- Select one:
Each of the required courses is available for public registration, course details and upcoming dates can be found by clicking on a course listed above.
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: Executive Management (C-Level) and/or Manager/Director level from Regulatory Affairs, Quality, Clinical Affairs, Manufacturing, Engineering, R&D, Internal Audit, Compliance/Legal, and Marketing.
If I took one of the required courses in the past, can I take the exam and have that course count towards a program?
For non-auditor courses, if you took the course in the past three years, you can ask 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 three years, there is no need to take another exam, and the course will count towards your program.
How do I sign up?
First, contact us and tell us you want to pursue a certification. 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 the links above or at orielstat.com/training and register for a session of your choice. We offer all of the courses in this program as open-enrollment classes--multiple times a 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.
