Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. It is important to consider the experience of CRO in that particular area and import...

FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after cus...

I would like to be a statistician . Clinical projects usually collects a lots of data so the statistician summarize the data so that non statistician can understand. A Statistician helps to optimize d...

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol' study flow chart .other costs should be ...

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol' study flow chart .other costs should be ...

The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication...

The Non-Conformance Material Report is used to report and disposition non-conforming material identified during inspection (Quality or Warehouse Inspection) or during the movement of the materials an...

Contract negotiation should be based on the uncertainty of scope, assignment of risks, need for predictable costs and importance of meeting milestones dates. Contract should be fair ,reasonable , and ...

Six Sigma uses statistical and numeric methods to reduce the number of defects in output to an insignificant level. It focus on understanding customer's requirement better and eliminating waste and de...

The QA and QC both are the part of Quality Management system .QMS takes comprehensive approach affecting the company's processes ensuring the safety and efficiency. QA is process oriented or procedure...

SV and CV are two essential parameter in earned value management and helps to analyze the project. If both are positive means project is progressing well but if one of the variance is negative then so...

A significant mistake in project planning is to assume full availability of all the team members. The management has the right to rearrange the employee vacation schedule to meet the deadlines. in the...

The process of identification and evaluating risks starts in the planning phase of the project and continues through out the project. It is important to determine each risk likelihood to occurring as ...

Risk is when an uncertain event or condition can occur and have an effect on the project outcome. Project manager tries to know everything about risks so that it could not effect negatively to the pro...

For any medical device manufacturer an FDA audit is a necessary and a potentially difficult part. The company should maintains proper documentation . The updated documents like DHF,DMR and dozens o...