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...

Adding to the discussion, systems approach to project management enables the project manager to constantly evaluate the needs of the customer and the ...

Different risk analysis methods like FMECA,FMEA includes (FMEA - PFMEA, Design FMEA - DFMEA), Root Cause Analysis (RCA),RCM (Reliability Centered Main...

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

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!. ...

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical d...

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 need...

In the closing phase closing phase process, all documents of the project both in terms of device delivery, and project management delivery must be com...

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 assigne...

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 mana...

Interpersonal skills is very important in negotiation. I believe a good negotiator should have some qualifications- for example: - Preparation and pla...

Introduction stage of a product life cycle, its a very important stage in the product life cycle, because the product manager should focus on marketin...

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 Ma...