Any item, part or product with one or more characteristics which depart from the requirements of the specification, safety, legality, regularity & quality or other approved product description. Nonconformity refers to a failure to comply with the requirement.A requirement is…   Read more»

For me, I will work as an engineer for 3-4 years and learn most of the technical stuff that I can use to enhance my career so that i have a proper experience and then I will shift to management…   Read more»

There are many factors to look for while preparing schedule and budget for clinical trials. 1. Start-Up Fees: This Start-Up Fee includes all of the Internal Committee and IRB application preparations, budget negotiations, regulatory document preparation as well as on-site…   Read more»

Analogous Estimating: This technique is used to estimate the project cost when very little detail about the project is available. Therefore, this technique does not provide a very reliable estimation. The primary benefits of this technique are its lower cost…   Read more»

Choosing the right supplier involves much more than scanning a series of price lists. The choice will depend on a wide range of factors such as value for money, quality, reliability and services. A key criterion in selecting the right…   Read more»

It’s a matter of Change of Management on the project, and as such should be already part of the project plan in the first place. Every project will face issues of one kind or another, and project plan should provide…   Read more»

Factors other than matrix that can help detect the status of the project and help us have a rough estimate of time frame for the project depends on how well we manage these factors: -Integration – Scope – Time/schedule -…   Read more»

Different project management metrics can be defined based on a project’s objective and complexity. However, the following five typically cover the most important measurements: Productivity – This metric allows project managers to assess the utilization of resources. It compares the…   Read more»

In my point of view some important aspects for consideration during design transfer and handing off the product are: Safety: The risk to humans or the environment Accuracy: The difference between the expected truth and the actual parameter Precision: The…   Read more»

Commitment to Customer: It is essential that the manager sensitizes the team that release plans once locked-in are sacrosanct. On-time delivery is key. Hence it is extremely important that the entire team is fully aligned to the customer’s requirements. The…   Read more»

Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the primary mode of action (PMOA) for the combination product (i.e., a new drug application (NDA) or abbreviated new drug application (ANDA) if…   Read more»

Six Sigma: Six Sigma is the method of choice for reducing variance and eliminating the number of defects that a process produces. Six Sigma relies heavily on statistical analysis and offers an arsenal of tools that analyze current performance and…   Read more»

The planning phase is the phase where the project solution is further developed in much detail. Its the phase where the steps necessary to meet the project’s objective are planned. In this step, the team identifies all of the work…   Read more»

Is it necessary to create a process group for every project by a company or a single process group looks after all the projects being done in the company?

A risk is an uncertain event which can have a positive or a negative effect on a project’s final product. As a project manager or a team member of that project, one of the important things I will do is…   Read more»

A risk to the product is something that every company faces, may it be a startup or a large established company. Risk management is something how the company or the firm tackles the risk.Risk Management is the process of identifying,…   Read more»

In my point of view each organization has pros and cons. but personally I feel that I am more comfortable working on a project based organization. Because in such type of organization, a person gets to work in various types…   Read more»

A Project Proposal is a detailed description of a series of activities that deal with solving a certain problem. It’s nothing but just converting the project plan into a project document. The project proposal should provide a logical presentation of…   Read more»

In my point of view, Science is a vast field and it is never too late to try new things. If we think that something has the capability to make a future in the market as a device, it should…   Read more»

According to FDA’s regulation, a premarket notification must be submitted to FDA when there is (a) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification…   Read more»