Production and Process Controls Practitioner Certificate
For medical device manufacturers, increasing complexity of products is generating more product quality and performance problems than ever before. The FDA is aware of this and has made Production and Process Control an area of intense scrutiny. Because of this, Oriel STAT A MATRIX has created our Production and Process Controls Practitioner Certificate Program.
About the Production and Process Controls Practitioner Certificate Program
Production and Process Controls (P&PC) is one of four major areas of the FDA’s Quality System Inspection Technique (QSIT) and it is covered during every FDA inspection. Medical device manufacturers must pay careful attention to this area to ensure compliance with 21 CFR 820.
Our Production and Process Control Practitioner Certificate Program will teach you to develop, conduct, control, and monitor production processes to ensure that your company’s devices conform to specifications. As well, you will learn how to troubleshoot and restore the necessary controls when deviations do occur.
Training Course Requirements
To earn your certificate, you must complete the following training courses, and pass each course examination. You will have up to 36 months to meet these requirements.
- Process Validation Principles and Protocols – 3 Days
- Calibration Requirements and Equipment Controls for Medical Devices – 3 Days
- Implementing Design Control Requirements and Best Practices – 3 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: Manufacturing, Production, Quality, Quality Assurance/Control, Engineering, R&D, Product Development, and Internal Audit.
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 3 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 3 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 the certificate programs 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. Contact us for more information about the on-site option.
