Hi, Here are other few, out of court dispute resolutions which are referred to as Alternative Dispute Resolution (ADR). Minitrials A minitrial is a process by which the attorneys for the parties prese...

Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other health care providers financial incentives to use the business’s products or services, for which payment may b...

Krunal, Nice discussion topic! The term ‘verbal contract’ actually refers to any agreement which can be expressed in words, and that means all written contracts as well as those that have only been di...

As Dr.Simon mentioned, there are several types of organizational structure which a company can function within, each having their own set of advantages and disadvantages. Consider collaboration projec...

As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project manag...

This is a good discussion topic related to the organizational structure. According to PMBOK, organizational structure is defined as an enterprise environmental factor which affects the availability of...

One of the points for avoiding risk I would like to add to manage risk is Exploitation. Exploitation: To exploit the risk. The techniques mentioned above are great when they have a negative impact in ...

Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project ca...

Risk index number = impact of risk event x probability of occurrence The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible im...

Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 task...

As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an ...

As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the...

Great discussion so far! Verification and validation are two critical elements of product development. One informs the elements of a product’s design, while the other looks at those design elements i...

Design Development Plan (DDP) contains: *final scope statement *scope management plan *quality management plan *communications management plan *team member list/responsibilities Communication manageme...

“Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design...