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
Scott Wilson - Team Bradley
Employer Partner Feedback
Dawn has been a pleasure to work with. She is diligent in her efforts to give MicroTrain’s students the best opportunities to connect and network with various companies and players in the job market. The curriculums and certification programs are in line with today’s current IT needs. It’s good to see that they evolve with what employers are most seeking out there. I would recommend to any employer that hires skilled IT workers that they look into MicroTrain’s career services department as a potential source of candidates. The business of hiring can be quite costly, and Dawn and her staff provide a free service to outside companies. This value-add for MicroTrain’s students aligns with their mission in both training and job assistance to set up a win/win scenario for all involved.
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!
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.
Kaycee Ekufu
MCSA
The instructor [Al Khalfan] was very knowledgeable in the field. He presented the materials and concepts with a professional touch. He also frequently adds humor to his teachings, which made it easier for me to understand. The support staff was all nice, gentle, caring, and very helpful. The materials, rooms and amenities were excellent and exceeded expected standards.
Ron Cwik
PMP Certification Training, 2008
Great training facility. Great instructors. Great experience.
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