Biopharma Institute Reviews 317

Easy to use. Good content and tests throughout course to emphasize important points.

The content was totally applicable to my industry. I only wish that there could have been more real life examples to compliance issues or things to watch out for.

It was easy to sign several people up at one time. The class was informative & pleasant to listen to.

Good program to educate people

The exam does not show you which questions you got incorrect. The exam did not really reflect the content of the course. The course content was good, however exam questions were not so good.

Self paced learning is best for me right now. The CRA professional certificate was exactly what I needed to learn the process of clinical trials.

Thank you for this course

I needed a refresher and it was perfect!!

The information is clear and concise making it easier to understand and remmember.

Very easy to understand and follow. Would recommend!

The course provides little value in understanding the core of the MDR and instead acts as sales pitch for taking the remaining courses. It would have been more useful to include things like an overview of the requirements, comparison to the major updates from the MDD, etc.

The section of the training about Implantable Pacemakers and Defibrillators is inaccurate and incorrect. The example used is that of patient with an intra-aortic balloon pump. During the story, they show pictures of implantable cardioverter defribrillator (ICDs) and pacemakers even though the device that is described in the video is a portable intra-aortic balloon pump which is an entirely different device. Pacemakers and ICDs have internal batteries whereas the pump has an external battery. The battery on patient's pump was thought to be fully charged before his ambulance trip; however, the battery was depleted and/or was faulty. The video states that “with no spare battery on board, the transport team was helpless” and that therefore, the device was at fault. However: Why would you transport a critical patient with only one battery and no spare? These devices can be attached to AC power, why was that not done? Because of the safety risks associated with an inactive balloon, the devices can be operated manually; apparently that was not done either but rather the balloon was removed.

After this story, which had NOTHING to do with pacemakers and ICDs, the video goes on to assert that UK doctors say that current pacers and ICDs “Must be improved to reduce the risk of replacement” and that the current system “discourages the development of longer life devices” which ignores the facts that 1) there is a tradeoff between battery life and device size; and 2) even if the device could be supplied with an infinite battery (e.g., rechargeable) replacement of the device may still be necessary as the either electronic components of the device would eventually fail.

These distortions and inaccuracies make me doubt the other examples with which I have less industry experience.

Finally, the quiz at the end focuses on numeric or superficial facts rather than core understanding. Example: "How many chapters are in the MDR" Questions like this don't demonstrate comprehension of the material but merely the ability to recall random facts from the course.

Overall, I cannot recommend this course.

Hi there,

It was good course but you don't provide downloadable reading or learning material.

For the first few modules the system only informed me of my score. I would prefer the system tell me which questions I answered correctly. Aside from this, there was a great deal of well organized information.

Well-presented material and information. It is organized and concise, however, I wish it could be a bit more informative/detailed. This information added to my skill set which will undoubtably help me in my career in Quality Assurance. The material presented helps to reinforce my knowledge base so I can be a more informed contributor to my peers and group. Some real-life examples would be a good thing to add to the presentation. Your materials are top notch and I enjoy training on them.

Great historical examples and good overview for those new to the medical device industry.

I am taking this online certification course: Global Pharmaceutical Regulatory Affairs. I must say ,the course content is comprehensive and very well structured. It exceeded my overall learning expectations in every way.

I highly recommend this online course to anyone seeking a flexible and effective way to enhance their knowledge and skills.