RAPS - Regulatory Affairs Fundamentals
The Regulatory Basics bundle is ideal for new professionals, students and career transitioners who need to learn the core concepts and key principles for operating in the health product sector's regulated environment.
About this Course
The courses provide fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets. Paired together, these courses serve as an excellent foundation for regulatory affairs knowledge. This course is self paced training.
Outline
Role of the Regulatory Professional
Examine the evolution of the profession and a professional’s roles and responsibilities. It also outlines critical events and their impact throughout the product lifecycle for drugs, biologics and medical devices.
Pharmaceuticals: Definition and Lifecycle
Learn basic terminology as well as the lifecycle development stages including early-stage research, nonclinical and clinical trials, manufacturing, marketing and postmarketing.
Medical Devices: Definition and Lifecycle
Gain an introduction to general aspects of product and regulatory lifecycles. It also provides a brief history of medical device regulation and information on basic regulatory principles and concepts.
Introduction to Regulatory Affairs in the US and Canada
Learn about the agencies primarily responsible for regulating healthcare products in these countries—the US Food and Drug Administration (FDA) and Health Canada and review applicable legislation that drives their regulatory processes.
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Raves & Praise
Robert Graf
MCSA
Microtrain presents the course material in an interesting and concise manner. Microtrain gives the student all the resources necessary to pass the certification exams. Both the Chicago and Lombard facilities were excellent, and the staff goes to any length to accommodate any student changes.
Jennie
Student Employment Success - Project/Process Manager
My Career Services Manager was very friendly and helpful and had excellent follow-up. She seemed to really care how things were going and kept me moving in the right direction. The resources available in job search were great and the visibility that there were jobs out there looking for my skillset was promising. Additionally, the training, as well as having an updated resume stating the Microtrain course work I had taken made me feel more confident and marketable as I looked for employment. It showed that I was dedicated and took project management and process management seriously.
Jean S.
PMP Certification Training, Lombard, 2008
I was laid off for many months and not really getting many callbacks for my resume and no job offers. After I put the letters PMP on it, not only did I see an increase in quantity, but also quality of interviews. I had been spinning my wheels for 5 months, and after the PMP went on, I had 2 job offers in 6 weeks. It really was the "golden ticket"
Ron Cwik
PMP Certification Training, 2008
Great training facility. Great instructors. Great experience.
D. Easter
PMP Certification Training, November 2008
Thanks Microtrain for conducting a great PMP course that set me on a successful path to obtain my PMP certification. I have passed the test!
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