Forum Replies Created
RE: Restrictions for physician's gifts I feel that this isn't too strict. Even though it might start as someone just paying for dinner, it could lead to other gifts or people even expecting gifts simply because they did business with someo... |
In forum Consultants and Legal Basics |
7 years ago |
RE: Discussion Topic: Course conclusion and impressions I enjoyed taking this class. I feel like you are one of the only professors that prepares students for the real world. Even though NIH strongly encourages institutions to provide career services and h... |
In forum Consultants and Legal Basics |
7 years ago |
RE: Recent Examples of Kickback Allegations Eli Lilly Co was involved in giving kickbacks to doctors for many years involving diabetes and osteoporosis drugs. They gave free nursing services to those doctors. The nurses were supposed to health ... |
In forum Consultants and Legal Basics |
7 years ago |
RE: Forming a Project Team I would ideally want to work with people who I like as well as people who are experts. When I worked at General Dynamics Electric Boat, I collaborated with people who worked at the Naval Research Labo... |
7 years ago | |
RE: Effective way to culminate inter department silos I think the best way to get rid of the negative competition is to develop a rapport within the company between employees. This is done through company events. At a nuclear plant I use to work at, ever... |
7 years ago | |
RE: Discussion Topic: Your organizational type When I worked at General Dynamics Electric Boat, I feel it was more of a functional organization. The functional heads have a lot of power. I had a great rapport with my functional manager so I didn't... |
7 years ago | |
RE: How to run a risk management meeting ? To run a risk management meeting, first I would identify the technical experts that are related to that topic. Then I would get everyone in a room and I would have a brain storming session. I would fi... |
In forum Risk Analysis for Medical Devices |
7 years ago |
RE: Risk management methods As a nuclear engineer, risk assessment and management is very important. I wanted to highlight on one of the risk analysis tools used for risk management for nuclear power plants. When I worked at a n... |
In forum Risk Analysis for Medical Devices |
7 years ago |
RE: Manage Risk For high severity risk, I would use avoidance. I want to get rid of the high severity risk. The best way to do this is by avoidance because mitigation just lowers the risk of it happening, acceptance ... |
In forum Risk Analysis for Medical Devices |
7 years ago |
RE: a successful validation process To make a successful validation process you need to clearly state your inputs and make sure they match your user's needs. You must think critically about what each input means so that you can design a... |
In forum Introduction to Design Controls |
7 years ago |
RE: Verification Protocol I choose a Band-Aid. The verification protocol makes sure the inputs matches the outputs. I believe the inputs would be that it sticks to the skin but can be removed without much force and that it doe... |
In forum Introduction to Design Controls |
7 years ago |
RE: Design Review Meetings Design review meetings are critical for the success of the product. At my old company whenever I held a design review meeting, I would send out all the materials a few weeks before the actual meeting.... |
In forum Introduction to Design Controls |
7 years ago |
RE: What FDA Looks For In A Design Control System ? Above, a lot of people listed all the requirements but I wanted to elaborate on one. I think the FDA looks to see that the design changes were implemented. This might seem trivial but its something to... |
In forum Introduction to Design Controls |
7 years ago |
RE: Consequences Of Insufficient Design Controls Without sufficient design controls, a number of things can happen. Entire systems can fail due to the inputs not reflecting the standards of the industry. People can get fired after those entire syst... |
In forum Introduction to Design Controls |
7 years ago |
RE: Design input sources As Adrian stated above, past projects are a source of design inputs. To expand on this, the Design History File (DHF) of other similar projects would be a source of design inputs. The key to choosing ... |
In forum Introduction to Design Controls |
7 years ago |