Medical Device Courses | k-faulk | Activity

k-faulk replied to the topic "Non Compete Agreement" -

Sat, 26 Jun 2021 01:27:15 -0400

Posted by: @dbonanno1 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you… Read more»

k-faulk replied to the topic "Restrictions for physician's gifts" -

Sat, 26 Jun 2021 01:19:03 -0400

Posted by: @ljw3 I’d like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company’s policy is that I am not allowed to receive gifts of any… Read more»

k-faulk replied to the topic "Consultants in the Medical Device Industry" -

Sat, 26 Jun 2021 00:57:34 -0400

Posted by: @traceymraw I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or someone with a specialized skill… Read more»

k-faulk replied to the topic "What is a risk management file?" -

Mon, 21 Jun 2021 01:33:34 -0400

Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall… Read more»

k-faulk replied to the topic "Risk Management Mistakes" -

Mon, 21 Jun 2021 01:22:31 -0400

This thread is loaded with some of the most common mistakes in risk management. Here are the top five that I have been able to find: *A lack of security & business alignment *Limited visibility *Putting frameworks first *Giving equal… Read more»

k-faulk replied to the topic "Risk Management Tools" -

Mon, 21 Jun 2021 01:13:57 -0400

Posted by: @pjf22 When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other do not. I also believe that each tool can be used… Read more»

k-faulk replied to the topic "Minutes for meetings" -

Mon, 14 Jun 2021 03:46:52 -0400

Minutes are very important. Especially on a day when you’re just out of sorts. Even before zoom people would zone out on meetings, make lists to get them through the rest of the day, plan dinner, etc. It usually isn’t… Read more»

k-faulk replied to the topic "Design Controls in the other countries" -

Mon, 14 Jun 2021 03:43:06 -0400

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]… Read more»

k-faulk replied to the topic "What are Design Controls?" -

Mon, 14 Jun 2021 03:39:23 -0400

Design controls are how the FDA check that the medical device has been developed safely. It also ensures that the product you have placed on the market (or are attempting to rather) has been well thought out. There are nine… Read more»

k-faulk replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" -

Mon, 07 Jun 2021 03:11:18 -0400

This thread assuredly posses an ethical dilemma. My goodness, what to choose. At the end of the day, it is likely that the next Henrietta Lacks has, in fact, chosen to keep their tissues out of the hands of scientists…. Read more»

k-faulk replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" -

Mon, 07 Jun 2021 03:04:17 -0400

Hi @llefevre! You’ve giving a wonderful overview of why placebo is used as well as the fact that it is not harmful in anyway to the patient. Coming from the perspective of the COVID trials, I do think that once… Read more»

k-faulk replied to the topic "Discussion Topic: Having a "clinical background"" -

Mon, 07 Jun 2021 02:58:38 -0400

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact… Read more»

k-faulk replied to the topic "S-Corp vs C-Corp" -

Sun, 30 May 2021 00:05:58 -0400

Posted by: @hm243 Most known companies as stated above, follow C-Corp setup, while very few follow an S-Corp. The major difference between the two types of corporations is the taxation. With C-Corp, there is a required double taxation. As a… Read more»

k-faulk replied to the topic "Accepting job based on company." -

Sun, 30 May 2021 00:00:47 -0400

Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me… Read more»

k-faulk replied to the topic "Family Businesses" -

Sat, 29 May 2021 23:57:15 -0400

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2… Read more»

k-faulk replied to the topic "Sucess Factors" -

Sun, 23 May 2021 15:36:12 -0400

Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a… Read more»

k-faulk replied to the topic "Importance of Logging Work" -

Sun, 23 May 2021 15:29:53 -0400

Just now in another thread a young lady asked “How do you track when a project began to fail?” Now I may not have gotten the wording completely right but you get the picture. My response to her was to… Read more»

k-faulk replied to the topic "Project failure" -

Sun, 23 May 2021 15:25:29 -0400

@eowinomsm-edu Greetings Liz, I completely agree with your definition of what a project failure is considered to be. I think further if the project does get done but grossly behind schedule it failed. AND if the project has to be… Read more»

k-faulk replied to the topic "Talking about animal research" -

Sun, 16 May 2021 21:00:24 -0400

Posted by: @mduru I think it would be appropriate to say this topic is like a double edge sword. Just as with any controversy or disagreement, I think dialogue is the best way to go about it. Both side need… Read more»

k-faulk replied to the topic "Research for the Fututre or Now?" -

Sun, 16 May 2021 20:56:37 -0400

Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary…. Read more»

k-faulk replied to the topic "Ethics of Animal Testing" -

Sun, 16 May 2021 20:49:58 -0400

Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important… Read more»

k-faulk replied to the topic "Multiple Project Managers for one project" -

Sun, 09 May 2021 19:24:27 -0400

Posted by: @srg36 I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the… Read more»

k-faulk replied to the topic "How do you identify or become a good project manager?" -

Sun, 09 May 2021 19:20:31 -0400

Posted by: @tulikadasp I have no work experience in working in the industry. I am studying about project management and trying to learn how to be a good project manager. For a person like me, I can only learn in… Read more»

k-faulk replied to the topic "Applying for Project Manager positions." -

Sun, 09 May 2021 19:17:01 -0400

Posted by: @ktk4njit-edu It will be very hard for anyone who does not have an experience to get a job as a project manager. One thing you can also do is to study for your PMP(Project Management Professional) certificate. You… Read more»

k-faulk replied to the topic "Designing effective Communication management Plan" -

Sun, 25 Apr 2021 16:47:52 -0400

Posted by: @smitshah Is it better to design communication management plan just once for all the project in the company and documenting it as a SOP or is it better to have a communication plan that is specific to a… Read more»

k-faulk replied to the topic "Things to look for in a contract while selecting a supplier" -

Sun, 25 Apr 2021 16:42:49 -0400

Posted by: @as934 One of the most important things to have included in a vendor contract is the condition that they need to notify your company about any changes that they have made or are going to make to the… Read more»

k-faulk replied to the topic "QA vs QC" -

Sun, 25 Apr 2021 16:36:00 -0400

Posted by: @aasutosh-purohit In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other? So, some people mix these two up to the point that they are often used interchangeably. However, they… Read more»

k-faulk replied to the topic "Project failure" -

Sun, 18 Apr 2021 23:08:57 -0400

Posted by: @armoneee @asg49njit-edu Communication is a key part of being able to interact with multiple people in a group. Project Management involves being able to work within a team. Many projects can have different teams working towards the same… Read more»

k-faulk replied to the topic "Closing Phase" -

Sun, 18 Apr 2021 22:34:15 -0400

Posted by: @am2343 The closing phase is imperative to any project as it ensures all aspects of the project have been completed as desired. As discussed in the lecture, there are many different processes and tasks that must be completed… Read more»

k-faulk replied to the topic "The effect that organizational structures have on project management" -

Sun, 18 Apr 2021 22:23:58 -0400

Posted by: @armoneee @k-faulk I can see the struggles of having multiple bosses in a matrix structure vs having one main boss in a functional structure. The expectation and execution could look different to multiple people. Ultimately I could see… Read more»

k-faulk replied to the topic "Missing Milesons" -

Sun, 18 Apr 2021 22:18:01 -0400

@niya-j Niya, I agree. Communication means all the difference during projects. Really anytime we are working with a group of people. Also, yes, the PM should put together a team of people to make sure the job gets done correctly… Read more»

k-faulk replied to the topic "Project failure" -

Sun, 11 Apr 2021 23:34:11 -0400

I think there are many reasons projects fail. Many of which are going to stem from poor planning and the teams inability to adapt. If you get off to a good start and things begin to become rocky, it is… Read more»

k-faulk replied to the topic "Missing Milesons" -

Sun, 11 Apr 2021 23:20:43 -0400

Posted by: @llefevre A milestone is a significant point or event in a project, also milestones have zero duration because they represent a specific point or event. It’s inevitable that not all milestones are going to be met on time… Read more»

k-faulk replied to the topic "Discussion Topic: The critical path" -

Sun, 11 Apr 2021 23:13:26 -0400

My class. So, I teach honors chemistry which is required for graduating with an advanced diploma. The issue is some of the students get in the class and decide that it’s too hard AFTER the two week period when they… Read more»

k-faulk replied to the topic "Missing Milesons" -

Sun, 04 Apr 2021 19:51:23 -0400

Posted by: @naglaa-hemida When working on a project missing a milestone is a possibility, due to technical issues, environmental causes, or human errors. what are some ways to overcome and get back on track after missing a milestone? When milestones… Read more»

k-faulk replied to the topic "Overlapping activities" -

Sun, 04 Apr 2021 19:46:43 -0400

Posted by: @delany I believe this is a refreshing way of looking at this type of situation. First, I do believe that returning to earlier phases will strengthen the overall project because it shows maturity and growth. Continuing with a… Read more»

k-faulk replied to the topic "Sucess Factors" -

Sun, 04 Apr 2021 19:41:26 -0400

k-faulk replied to the topic "Overlapping activities" -

Sun, 28 Mar 2021 17:47:11 -0400

The planning phase sets the foundation for the rest of your project. Although you may begin other steps of the cycle while still in the mist of planning having a good general foundation using information from past projects and team… Read more»

k-faulk replied to the topic "Closing Phase" -

Sun, 28 Mar 2021 17:37:01 -0400

A good closing phase is your stamp on that project. Of course you should properly close contracts and pay any outstanding bills. However the other steps are what will help your team members and other teams in future projects such… Read more»

k-faulk replied to the topic "Importance of Logging Work" -

Sun, 28 Mar 2021 17:29:12 -0400

About two years ago, I had a particularly difficult family in my class. (I know, whole families don’t take HS Chemistry. But stay with me.) The young lady was disabled. There was no mental delay however, her mother insisted she… Read more»

k-faulk replied to the topic "The effect that organizational structures have on project management" -

Sun, 21 Mar 2021 20:41:24 -0400

Posted by: @jteamer Many different organizational structures take various forms and have various impacts on projects and project management. Based on your own experience, what impact does can an organizational structure have on a project? One example that comes to… Read more»

k-faulk replied to the topic "The effect that organizational structures have on project management" -

Sun, 21 Mar 2021 20:35:23 -0400

Organizational structure has a huge impact on the project. If you are in the project based or functional organization, it may be a bit easier because you only have one immediate boss. And that boss knows what you are supposed… Read more»

k-faulk replied to the topic "Your ideal PMO type?" -

Sun, 21 Mar 2021 20:28:44 -0400

Maybe it’s the teacher side of me, or the nosey side, but I would like to be in the supportive role. I would like to be able to teach teams new or different ways to meet their goals. Especially since… Read more»

k-faulk replied to the topic "How To Avoid Repeated Mistakes in A Project Management Team?" -

Sun, 14 Mar 2021 18:56:32 -0400

Posted by: @kbentleymsm-edu This is only my second week in project management. I still feel like I “just don’t know” how a project looks. I guess a practical, simple example would be nice to see. Admittedly, I feel a little… Read more»

k-faulk replied to the topic "How To Avoid Repeated Mistakes in A Project Management Team?" -

Sun, 14 Mar 2021 18:48:35 -0400

As a team, it would be self sabotage to continue to make the same mistakes over and over again. And as we have learned from Dr. Simon, a good Project Manager should have a log of what goes wrong. In… Read more»

k-faulk replied to the topic "Interpersonal skills vs technical knowledge" -

Sun, 14 Mar 2021 18:39:53 -0400

When I was first hired as a chemistry teacher, one of the interviewers, the senior chemistry teacher of the school commented, “You have all the right stuff on paper and you interview well. I’m not questioning whether you’ll be able… Read more»

k-faulk replied to the topic "Team member skills" -

Sat, 13 Mar 2021 23:44:59 -0500

Posted by: @naglaa-hemida We all start as team members to be a project manager, and it takes time, effort, passion and determination to be a good project manager. However, what are the skills that we should be looking for in… Read more»

k-faulk replied to the topic "Emotional Intelligence" -

Mon, 08 Mar 2021 01:02:01 -0500

Posted by: @llefevre Having a keen sense of Emotional intelligence can be the glue that melds together multiple personalities combined with empathy and understanding to ultimately accomplish any project. @llefevre Hi Lentz! I completely agree with this statement. While… Read more»

k-faulk replied to the topic "Emotional Intelligence" -

Mon, 08 Mar 2021 00:52:47 -0500

In my school district we have an academy system. Each of the four high schools host five academies one of which, the freshman academy, can be found at all of the schools while the other four are unique. This system… Read more»

k-faulk replied to the topic "Team member skills" -

Mon, 08 Mar 2021 00:22:54 -0500