Hi,

To be successful, project teams must work together to an accomplish a goal, and usually that goal is finishing the project on time and within budget. But, there is more to selecting a team than simply choosing a bunch of people. You have to ensure that the people have the required skills and that they can work together.A great project team…[Read more]

Hi,

A organization structure defines a reporting relationship in company.I currently work in a functional organization. Once we get a project, we work as a team and submit the project on time .We do not have any communication with other department.Being the part of good team is what really matters here and there is only sharing of information…[Read more]

Hi,

A organization structure defines a reporting relationship in company.I currently work in a functional organization. Once we get a project, we work as a team and submit the project on time .We do not have any communication with other department.Being the part of good team is what really matters here and there is only sharing of information…[Read more]

Hi,

I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without reported harm.
Likelihood of risk considers three risk…[Read more]

Hi,

I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without reported harm.
Likelihood of risk considers three risk…[Read more]

Hi,
I did some research and in my opinion the best way to address risks is pseudo-quantitative method is probably the risk matrix, which classifies the likelihood of a risk in one category and the consequences in another category. The combination of the likelihood and consequence categories corresponds to a risk level, usually a color such as red,…[Read more]

Hi,

I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA’s premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully any potential risks were assessed by the manufacturer. In addition, an evaluation…[Read more]

Hi,

I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA’s premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully any potential risks were assessed by the manufacturer. In addition, an evaluation…[Read more]

Hi,
To complete a project successfully, you must control a large number of activities ,and ensure that they are completed on schedule. If you miss a deadline or finish a task out of sequence, there could be a knock-on effect on the rest of the project.It could deliver a late result. That’s why gantt chart is helpful to see everything that needs to…[Read more]

Hi,

A design review is a milestone within the product development process whereby a design is evaluated against its requirements in order to verify the outcomes of the previous activity and identify the issue and correct it . There are different ways to conduct a design review 1. physical test 2.examination (walk-through).The ultimate design…[Read more]

Hi,

I agree with the above discussion, following are the problem during design transfer.
1. The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures.
2.The purchasing department does not have enough time to identify and approve new vendors, verify component specifications,…[Read more]

Hi,
Design control are interrelated set of practices and procedures that are incorporated into the design and development process.A design control provides a systematic assessment of the design an integral part of development. As a result ,deficiencies in design input requirements, and discrepancies between the proposed design and requirements,…[Read more]

Hi,

I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes are under production control and all changes must be documents in the DMR/technical file.

As per 21 CFR Part 820 DHF means compilation of the…[Read more]