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akshayakirithy replied to the topic "Non Compete Agreement" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Restrictions for physician's gifts" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Upper vs Middle Management." – 5 years, 10 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,… Read more»
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akshayakirithy replied to the topic "Effective way to culminate inter department silos" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Upper vs Middle Management." – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Manage Risk" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "How to run a risk management meeting ?" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Risk Management Mistakes" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Deviations That Occurs During Verification" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Minutes for meetings" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Design Controls in the other countries" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "What FDA Looks For In A Design Control System ?" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "CRO or Big Pharma" – 5 years, 10 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… Read more»
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akshayakirithy replied to the topic "Discussion Topic: Having a "clinical background"" – 5 years, 10 months ago
It is not necessary to be from a clinical background. Basic knowledge of human biology would be helpful in this profession. Also, if a person is well enough to do this profession he must be very clear with the processings… Read more»
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akshayakirithy replied to the topic "Clinical Trial Roles" – 5 years, 10 months ago
I would like to work as a Clinical Investigator where the causes and effets of any process would be estimated. It is a very interesting role where we could connect the trials results with the effects. Each and every details… Read more»
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akshayakirithy replied to the topic "R&D vs Quality" – 5 years, 10 months ago
R&D and Quality control are two different sectors which are dependent on each other. Even though research of a particular product would inititate the development of a product, the application of the particular product into the real world would never… Read more»
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akshayakirithy replied to the topic "Clinical Studies" – 5 years, 10 months ago
I have involved in the human research study were we worked on the TBI and ADHD subjects and the research was related to attention. I see the pros and cons of the human research study to be an equal one…. Read more»
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akshayakirithy replied to the topic "Public vs. Private Companies" – 5 years, 10 months ago
Public companies has employees that increase the shareholder value which remains long trem. Private company becomes public when it shares its stocks in front of public. Private companies tend to see profit unlike public companies which invest their profit shares… Read more»
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