As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either throug...

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instea...

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance pathway. For example, Canada and the US have a mut...

Assuming that once a smaller companies has identified a suitable clinical trial management company to contract with, payment could become a key part in managing the contract between the two companies....

One factor which can make or break communication within a clinical trial and project is communication latency. The time from delivery to acknowledgement of a message can be critical when it comes to c...

One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical trials may be the quantity of patients a company ...

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company call...

WBS should be closely aligned with a company's risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as wel...

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate the trade-offs faced when pressed for time. A proje...

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects ...

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the project lessons without working off of them could ...

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeholders prior to the design review meetings. Stakeh...

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it co...

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for ...

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the...