One thing that I would like to expand on from ap962’s post is assigning a dedicated vendor manager. It is good to have a single person designated as the contact person with a vendor in order to avoid sending the…   Read more»

It is possible for a project to have multiple priorities, but it is important to make sure that these are included in the scope of the project. It is also important to remember that widening the scope of the project…   Read more»

Once of the most important things that I will take away from this course is the value of good planning. In industry, I have been part of project teams with poor planning and with good planning. On the projects with…   Read more»

Preparing a schedule for a clinical trial is done using the same tools that were used for others projects: by creating a WBS and a Gant Chart. The WBS should include pre-study tasks, study tasks, and post-study tasks layed out…   Read more»

I think that it is a combination of the culture in America as well as the individual’s inner motives. America’s businesses are valued at how successful they are, and 50-60 hour work weeks stem from the idea that working longer…   Read more»

Retaining good talent is important, especially within medical device companies where historical knowledge of the product is very valuable. As stated in the posts above, the key to retaining good employees lies in keeping them motivated. On a scale of…   Read more»

An excellent point that ks629 brought up is that historical knowledge of the products at a medical device company is invaluable to the company. If a company has a culture where engineers are hired only for the duration of a…   Read more»

While it may be beneficial to have a broad communication management plan defined in an SOP, I think that communication management plans tailored to individual projects are more beneficial. This allows for the Project Manager to lay out exactly how…   Read more»

One of the most important things to have included in a vendor contract is the condition that they need to notify your company about any changes that they have made or are going to make to the components that they…   Read more»

Changes can be made to design control documents, SOPs, DMR, BOM, DID, DDP, DSD, verification/validation protocols, and the risk management plane. Changes will go through a design review process during which documents are reviewed, changes are made if necessary, and…   Read more»

An additional factor that I would add onto the list that Aasutosh suggested is performance. While resources (people) may be available, if the work is not satisfactory then things will need to be redone. By monitoring performance in addition to…   Read more»

One thing to consider when handing over a product from development to production is to think about the person that will be assembling the device. During development, the product is generally being assembled by the engineers that are coming up…   Read more»

In the last project that I worked on, a major source of delay for the project came from lack of project resources. Resources which were needed in the second half of the project were promised to the team at the…   Read more»

As stated in earlier posts, Planned Value is the expected value (or amount completed) for the project on a certain date, and the Actual Cost is what the project actually ends up costing. These two values matter in the Monitoring…   Read more»

In my project team, we have a tab on our project dashboard with the vacation schedules and proxies of every single member of the team. This allows everyone to be aware of any planned vacations ahead of time, and who…   Read more»

Successful project execution relies upon completion of the activities in the WBS, following the guidelines in the DDP, and completing tasks and work packages. In the role of Project Manager, it would be important to emphasize that all project team…   Read more»

As cs22 had mentioned, the response to a failure depends on the severity of the problem. Throughout the project it is important to meet the requirements that were laid out in the beginning. If failures occur with experiments and with…   Read more»

I agree with f-dot and msc52 about the suggestion of adding an “Updates” step to the steps of project scheduling. This allows for the project manager to be aware of any potential delays to the original timeline, and will allow…   Read more»

Another thing that might be included in a verification report is sample traceability. In the reports used at my company, there is a place to fill out part numbers, lot numbers, and production date of the samples that are used…   Read more»

The risk of not meeting the planned dates, particularly the Late Finish (LF) date, can be mitigated by including some buffer time, as smk45 suggested. During the project planning phase, you want to make sure you account for and mitigate…   Read more»