Personally, I believe that it is both necessary and in good business practice to separate family and business matters in today’s world with all the guidelines and laws in place. This remains true even during ‘business trips’ where a rep…   Read more»

In my line of work, I had extensive experience in the manufacturing and testing of high throughput, immunoassay, analytical instruments that are used in many hospitals around the world. Having this experience and knowledge, if I were to apply to…   Read more»

To add to the discussion about advice when signing an NDA, I would like to emphasize the point of fully understanding the magnitude of consequences that may be leveraged against you on the occasion that the agreement is broken. While…   Read more»

When looking inward at myself and asking if I would be a better suited in upper management or middle management, I would say that it is a tough decision. However, I would have to choose upper management because I believe…   Read more»

If I were charged with forming a project team, I would assemble a group of individuals with similar guidelines as aaq2 mentioned above valuing skills and abilities the most. However, it is important to note that I would also heavily…   Read more»

In my current position, I believe it is mostly a functional-based organizational structure with minor aspects of matrix organizational structure. For the most part, there are supervisors (functional managers) of different departments. My direct supervisor has a lot of power…   Read more»

In general, I agree with the above comments that state that lower risks can mostly reasonably be managed by using the strategies acceptance and/ or mitigation. This makes sense because if it is relatively low risk, the consumer most likely…   Read more»

To add to what was said above by both Mark and amandaally1029 in the above comments, another factor to consider would be the “Availability of alternative treatments or diagnostics”. This is a critical factor to consider because it would not…   Read more»

Adding to what was mentioned by amandaally1029 above after the risk analysis is completed in the FMECA technique; a critical decision must then be made by the heads of the company. That decision is: does this product’s risk outweigh the…   Read more»

In agreeance with Scott’s comment about the extent of the validation required, I have experience with similar guidelines in my position. Firstly, a standard is set for the immunoassay instrument to meet of the concentration of known analyte it is…   Read more»

Siemens Atellica Solution Immunoassay Analyzer: The extensive verification process of the Immunoassay Analyzer’s generally consists of the instrument and laboratory diagnostic verification. In the instrument verification state, each subassembly must pass its designated test, confirming that it is working as…   Read more»

Adding to what myton said above, the process of verification also is generally an internal check to make sure the product follows its initial design specification. A good product will stay true to these original regulations, specifications, and regulations that…   Read more»

In addition to the detailed outline of meeting minutes made by woolynn and others above, I would like to add that the minutes are not an exact transcription of what each individual had said in the meeting, rather a comprehensive…   Read more»

As many have said above Gantt charts are one way of organizing the timetable of mini projects that comprise the overall product. My experience in industry pertaining to Gantt charts involves working with the manufacturing supervisors to come up with…   Read more»

After doing some research, I chose to pick an area where design controls were not in place. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005)….   Read more»

It is my personal opinion that when a person consents (signs) to having an operation/ procedure done which results in the removal of an organ/ bodily fluid, the patient waives any rights/ ownership they had over the now extracted substance….   Read more»

In addition to the valid pros reshanm and ppp23 made, I would like to highlight that in a lot of cases, the patient volunteering to undergo clinical trials does not have to pay much (if any) out for their own…   Read more»

It is my belief that placebo controlled studies are necessary and ethical, yet should not be the “proof” that a drug/ medical-device combination is effective. This is due to the many curiosities that still surround the idea of a placebo…   Read more»

Siemens Vision: A world of proven talent delivering breakthrough innovations giving our customers a unique competitive edge enabling societies to master their most vital challenges and creating sustainable value. Mission: Within the scope of Siemens’ core activities, to find the…   Read more»

While some products hold firm to the traditional television commercials, there are a great deal that are utilizing different mediums of advertisement to market their product to their target audience. As mentioned by amandaally1209 above, some companies have already made…   Read more»