I also agree the motivation the project manager has, can be effected into the other members. And I think its important for the project manager to know that the outcome of the project should be constantly made aware to the…   Read more»

There is always a benefit to retaining talent. Experience employees are very important to the furtherance of any company. This is where star player and people of ordinary characters can come in and make a difference. However, it starts being…   Read more»

Personally, I feel like if people don’t work just to make a living at a comfortable position then they are seeking some way to leverage their skills and advance them by becoming more knowledgeable and versatile. Many people end up…   Read more»

I think that there should be a communication plan documentation that is kind of generic like an SOP, however depending on the structure of the company this may not always work. If the company is one which departments have their…   Read more»

I think this is extremely important because the most important element of any project or system, is the human element. By insuring that the more suitable person for the job is selected can result in the product being nurtured in…   Read more»

I also agree that the contract should clearly say all the needs to be said about eh expectation of the interaction between the vendor and your company. Especially changes that they may make to the design of your procurement. For…   Read more»

In the control phase any financial values can change based on the project dynamics. Usually the cost can be seen in the phase before the control phase and after where resources are established and assigned to a specific need. However,…   Read more»

There are usually CAPA that are open to address these failures that are managed by the department head and the quality system. If there are failures with regulatory there is not must that can be done except to deal with…   Read more»

When keeping up with milestones, one of our greatest tool is communication. We made sure we always gave updates on our every part of the project to the project manager to always make predictions on whether or not we would…   Read more»

The validation check is a design step that insure that the input meets the user intent, if it does not then the design is incomplete or simply something else. I think that depending on the limitation that is preventing the…   Read more»

The work that the team would have to do should be design with contingencies in the event of a member suddenly not being present. Some of the things I have seen in y experience is have very open dialog in…   Read more»

I definitely agree that the planning phase would have to be revisited and redone. All the factors that are essential to the packaging line must be evaluated and it’s economic needs must be known. In my experience if the budget…   Read more»

I have experienced this quiet a few times as I work closely with PM’s. So anytime there is a change in a PM, due to any reason either the PM leaving or a senior PM taking over the project, there…   Read more»

I have worked on a project where we had to design a system where we had to have all our lab equipment backed up to a encrypted server. Some of our challenges were the risks that came with having different…   Read more»

I am part of out weekly design control meeting for our company’s new product, we have a meeting where we discuss how we can improve the batch records and we assign task based on a tracker that we constantly update….   Read more»

I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked on a project where the team leader main concern was the qualification…   Read more»

I worked on a project where we had to collaborate with a different company or our validation projects. Because I was more familiar with the system and they were basically adding to our current system I basically came up with…   Read more»

I currently work in the pharmaceutical industry, most of the projects I work on was around building up our current labs to GMP standards. However, I had work of several different project with different department to do so with a…   Read more»

I also agree that the culture of the group is very important. It can get off to a rough start if the initial team is not very compatible . This is especially true when the project is ongoing or will…   Read more»

In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modification that do not need animal testing but may still require a…   Read more»