Preparation is the key to turning a design review from meeting a formality to becoming a milestone․ An effective technique is to have an internal design freeze days before the milestone review․ Setting that cutoff forces the team to finish…   Read more»

A helpful way to think about early start and late finish is to connect them directly to how the network diagram is built during the planning phase. After the team organizes tasks into a Work Breakdown Structure and defines their…   Read more»

The tension between technical readiness and market enthusiasm is a significant challenge in medical device development. Early client interest can validate the concept and motivate the team, but it can also distort risk perception. When clients build around unqualified or…   Read more»

That is an interesting question because the answer depends on what someone expects a certification to represent. From one perspective, the Google Project Management Certificate functions more as a structured training pathway than a traditional credential. It focuses on practical…   Read more»

An interesting way to approach this question is to separate frequency from severity. In most projects, resource risk is the most visible and therefore the most present type of risk. Teams often suffers from a shortage of personnel with the right…   Read more»

Risk transference in the pharmaceutical and medical device industry often appears in structured partnerships where a third party assumes defined operational or financial exposure. Instead of conducting all activities in-house, these companies have formal contracts and quality agreements with specialized…   Read more»

Hello everyone,
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Another view, however, based on the principle that the DHF should be kept as an active engineering record and not just an archive, is that documentation problems occur because engineering teams maintain separate technical and regulatory records. If teams focus…   Read more»

A balanced Design Development Plan is more focused on priorities than on task-level detail. This allows companies to set key regulatory, performance and decision checkpoints, rather than trying to prescribe every step in detail before beginning. With these elements fixed,…   Read more»

An alternative way of thinking about design reviews is not as a checklist where team members review documents and complete forms, but as an active session where team members question the validity of the assumptions. Because no one is watching…   Read more»

One view is that the best way for organizations to balance innovation with compliance is for Design Controls to be part of the organizations’ regular project management processes. The lecture material shows how Design Controls are integrated into the PDCA…   Read more»

One way to look at this issue is through how the PDCA cycle separates planning from execution. In the accompanying slides it states that the design inputs are the high level customer requirements for a product, while specifications are the…   Read more»

The guidance states that the methods used for verification and validation do not need FDA approval before use. However, it says that the methods must be consistent with the FDA’s design control system, which includes such elements as planning, verification,…   Read more»

In the event of verification failure, the scope of pressurization is often to solve the visible problem, not to see why it did not meet the requirement. In the case of the labels failing under water submersion, the requirement was…   Read more»

In medical device development, organizational structure strongly influences how smoothly technical work, testing, and regulatory activities stay aligned. A purely functional organization can build strong depth in areas like design, quality, and manufacturing, but information often moves slowly across departments,…   Read more»

The key differences are whether the device represents such a meaningful change that it raises new questions of safety and effectiveness for patients, and how much new information needs to be obtained by the FDA to determine whether the device…   Read more»

Even for someone who does not plan to become a project manager, a working knowledge of project management is still important because most technical roles operate within a structured project environment. In areas like medical device development, tasks are tightly…   Read more»

In group projects, roles should exist, but they should remain flexible rather than fixed. On the other hand, defined roles reduce confusion, missed activities and duplicate work, but on the other, by being too rigidly defined, members only do what…   Read more»

A useful way to think about project managers, as compared to program managers, is in terms of the level at which they operate. The project manager is responsible for leading the temporary endeavor defined by project scope and objectives, and…   Read more»