1)Who should do the communication on a project dependent on the organization set-up? Communication in any project is an essential tool for a PM, also regardless of your role on the project, you must l...

Adding to the discussion, systems approach to project management enables the project manager to constantly evaluate the needs of the customer and the end results that are needed to be achieved in term...

Hi All, As we have learned, WBS is a tool to define “what” you are doing. Also, there are three reasons to use a WBS in your projects 1- It helps more accurately and specifically define and organize t...

Different risk analysis methods like FMECA,FMEA includes (FMEA - PFMEA, Design FMEA - DFMEA), Root Cause Analysis (RCA),RCM (Reliability Centered Maintenance), and Risk and control self assessment (RC...

CAPA is required under 21CFR820.100 It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action. CAPA is important to continuous improvement...

I thing the biggest advantage for internal audit, it gives you a chance to verify that your CAPA have been completed effectively and on time or not!. Also, the ability to identify non-compliance thing...

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical device for example. GMP is also sometimes referred ...

Budget cuts doesn’t affect the cost estimation of the project. However it does affect the scope or quality of the project. A good project manager needs to resist that pressure and make sure that any c...

In the closing phase closing phase process, all documents of the project both in terms of device delivery, and project management delivery must be completed. Project actual results are reported and do...

I think all the factors listed are very important for a project, and I think the most important thing is to Develop clearly defined plans with assigned responsibilities. For each task in thee project ...

Actually all the factors listed above are a very important tools for a successful product manager, but I think its very important for the product manager to Stay informed about industry and market dat...

Interpersonal skills is very important in negotiation. I believe a good negotiator should have some qualifications- for example: - Preparation and planning skill. - knowledge of the subject matter bei...

Negotiations always involve people, so it stands to reason that it is necessary to have a good social skills and strong emotional intelligence when negotiating. When you have emotional intelligence, y...

Introduction stage of a product life cycle, its a very important stage in the product life cycle, because the product manager should focus on marketing,advertising, pricing , distribution, and promoti...

The FDA recalled GE MRI in 2015. Reason for Recall: Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The MRU is one method use...