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
Karine Bucci
Project Management
Great class, loved the interaction and team-building exercises. Plenty of materials and learning tools supplied. Although it was a full week's class, never boring. Donna [Russell] was awesome and gave many supporting examples for better understanding.
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.
David
A Cisco Success Story
I attended a resume writing seminar & conducted mock phone interviews with a Microtrain career counselor. These two activities gave me a leg up on distinguishing myself from all the other people looking for work. Since the career counselor's at Microtrain had a track record of getting people hired, their insight and positive past experiences helped me tremendously in getting hired with a Cisco Voice Systems Integrator in the Chicago area. I was hired as a Cisco Voice Tech Engineer with a starting salary of $65,000 / year with a Cisco voice systems reseller located in the Chicagoland area. Microtrain was very instramental in making this a reality. From expediting my WIA grant, to providing excellent hands-on training from knowledgable instructors I was able to achieve becoming certified with my CCNP. Microtrain's career services was the final catalyst in connecting me with this company by communicating with them on my behalf and with me in setting up the interview. One week later and I was hired. No joke. Thanks Microtrain!
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"
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