-
akshayakirithy replied to the topic "Difference" – 6 years, 2 months ago
In my point of view both does has same responsibilities. I don’t find any difference between Project Manager and Clinical Project Manager. Clinical refers to the domain in which he is involved to handle the project. Let’s consider a Software… Read more»
-
akshayakirithy replied to the topic "Human Factors study in combination products" – 6 years, 2 months ago
The Human Factor Study produces combined devices or products which combine a device, drug or biological element which is totally different from the conventional method. As mentioned by the given link the combined products are formed by three different ways…. Read more»
-
akshayakirithy replied to the topic "Discussion Topic: State of your Organization" – 6 years, 2 months ago
I don’t have any experience in any industry or organization. I feel that if I work in a project based organization at the onset of my career I could develop my technical skills and learn how to work in a… Read more»
-
akshayakirithy replied to the topic "Project Manager Skills" – 6 years, 2 months ago
An efficient Project Manager should be a good leader who has certain important qualities. First of all he should inspire others and should project his goals to the team convincingly. Leadership is successful only if the team is ready to… Read more»
-
akshayakirithy replied to the topic "Discussion Topic: Projects of all types" – 6 years, 2 months ago
It’s not easy for a PM to adopt himself into a domain where he has no connections. PM can be thrown out of his field to work for another but before working under a project which is not related to… Read more»
-
akshayakirithy replied to the topic Non Compete Agreement in the forum Consultants and Legal Basics 7 years, 8 months ago
Thanks for starting up this discussion. I really had no experience of this. But these posts made me to look through what is happening with respect to the Non Compete Agreement. In contract law, a non-compete clause (often NCC), or covenant not to compete (CNC), is a clause under which one party (usually an employee) agrees not to enter into or…[Read more]
-
akshayakirithy replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 8 months ago
I feel verbal agreement is the better way and trustworthy too. We are now in the world were even a conversation between a professor and students are being documented if it is via mail. For discussing about something personal life and relationships it is far better to go with oral agreements. But in case of business were dollars will be invested…[Read more]
-
akshayakirithy replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 7 years, 8 months ago
You have given a good point. Rules of Educational gifts are acceptable but setting up a limit of $100 is not a good one. At least the amount limit should be increased. Also, there is no point in taking a wife for a business meeting unless she is also involved in business. Dealing the business with a professional attitude is better. So I can go…[Read more]
-
akshayakirithy replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 7 years, 8 months ago
I agree with nititnhebbar and other who believe that at this stage, middle level manages will best suit us. Experience in the field and aligning to the vision of the company is a must to think strategically. Unlike upper management, middle-level management generally set tasks and set milestones to project members that are monitored by lower level managers.
-
akshayakirithy replied to the topic Effective way to culminate inter department silos in the forum Organizational Development in Device Companies 7 years, 8 months ago
I agree with srg36. Interdepartmental team building events have really gelled other department, connected various individual and has made many people as team players. rather than considering inter-department silos as a result of competition, I believe that ego is the factor. Sometimes, meetings are just arguments rather than solution since…[Read more]
-
akshayakirithy replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 7 years, 8 months ago
I believe that to think strategically and manage a range of projects, it is important to understand the work culture and have some experience in that field. I agree with a0242 and all others who said that right now being suited to our level of experience. I can implement the tasks assigned to my team at a middle-level manager, think tactically and…[Read more]
-
akshayakirithy replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 8 months ago
I take avoidance for the high severity and transference for the low severity. Prevention is always better than cure. So avoidance should be taken into consideration first. Every step should be keenly surveillanced and specific measures should be taken. It’s all upto thinking out of the basket. However, some critical issues should be solved with…[Read more]
-
akshayakirithy replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices 7 years, 8 months ago
For a Risk Management Meeting it’s really important to have all departments heads. If there is any change in the design, then it affects all the further steps in a mild or a severe way depending upon the change. Whatever it is we have take everything into consideration. In regulatory, the changes should be checked whether it is under all the…[Read more]
-
akshayakirithy replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 8 months ago
That’s a good one. The differentiation between the Design Controls and Risk Management was well clarified. This is like a general idea. Whatever we work on, if there is any change from the prior planned method we should concentrate on the effects that it cause. It might be in a common game or a business, if there is a modification in the strategic…[Read more]
-
akshayakirithy replied to the topic Design Verification & Validation vs Clinical & Pre-Clinical Trials in the forum Introduction to Design Controls 7 years, 9 months ago
There are number of medical device which are used outside the body. For instance, we can even take glucometer. It is a device used outside the body only to measure the glucose level in blood. Verification and validation is necessary for this device. When device is not used inside the body or invasive most of the time clinical trial won’t be a…[Read more]
-
akshayakirithy replied to the topic Deviations That Occurs During Verification in the forum Introduction to Design Controls 7 years, 9 months ago
Verification is of course an important step. I would like to say that this verification step as statistics with respect to research. In research, although we get the result we should check whether the stats shows the same difference. I was involved in a human study where demographic details would play an important role. Age, sex, race , education…[Read more]
-
akshayakirithy replied to the topic Minutes for meetings in the forum Introduction to Design Controls 7 years, 9 months ago
Creating an outline – as discussed earlier, having an outline based on the agenda makes it easy for you to simply jot down notes ideas under each item as you go along. If you are taking notes by hand, consider including space below each item on your outline for your hand-written notes. Check-off attendees as they enter the room – if you know the m…[Read more]
-
akshayakirithy replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 9 months ago
I see that there is brief discussion regarding the Medical Device regulation in India. There is no clinical trials or local testing of device if it is approved by other country market. I hope that this will be changed in near future. Being a most developing country in medical technology Medical device regulatory will be properly executed soon. But…[Read more]
-
akshayakirithy replied to the topic What FDA Looks For In A Design Control System ? in the forum Introduction to Design Controls 7 years, 9 months ago
Depending upon the class of the device FDA regulations do vary. The rules also vary accordingly depending upon the risk of the device. Device prototype is the most important part where a basic structure is shown and the properties and importance of the device is estimated.Refining the prototype provides researchers with important information about…[Read more]
-
akshayakirithy replied to the topic CRO or Big Pharma in the forum Clinical Research Basics 7 years, 9 months ago
Generally I feel that working in a small CRO is better. It makes you to develop yourself and gives you lot of experience to move in to the world of Big Pharma. Innovative excellence and growth in the career only happens if you know everything from the scratch of the domain. So it would be better.
- Load More