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...

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 ex...

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 th...

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 manageme...

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 t...

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 m...

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 relati...

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...

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: d...

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 me...

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 ins...

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 the...

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 mee...

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 w...

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 Medi...