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 important to consider the financial stability of…   Read more»

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 customer complaints. There can be number of reasons like health…   Read more»

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 design, analysis, interpretation of results and conclusion….   Read more»

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 considered like cost related with shipping. Always…   Read more»

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 considered like cost related with shipping. Always…   Read more»

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 reconciliation team is an important task for project manager for medical…   Read more»

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 and/or when the material is in stock. The material is inspected to verify that…   Read more»

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 beneficial to both parties not depends upon the smart party….   Read more»

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 defects. The objectives is to improve the organization’s products, services,…   Read more»

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 oriented as it focused on methods how to prevent…   Read more»

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 some corrective action are needed…   Read more»

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 absence of a team member the project…   Read more»

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 well as its effect on the overall project…   Read more»

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 project. Project managers know how to…   Read more»

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 of other demonstrates the commitment to quality , accuracy and…   Read more»

Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification should start at an early stage when design input are developed….   Read more»

The project closing phase is as significant and impactful as the Initiation, Planning, Executing, and Monitoring and Controlling phase. The impact of project closing can be extensive, both to the project and to the organization. The key benefits of this…   Read more»

A risk management team is a separate and often independent unit within the project management team headed by the risk manager .The team also develops strategies to mitigate identified risks, applies risk management methodologies and risk analysis tools, and integrates…   Read more»

The Planning/Initiation phase sets the foundation for the other phases. The execution phase is also an important part of project . Being the longest phase of project because there are three primary steps include building the deliverables, monitor and control,…   Read more»

The unresponsive team member’s communication delays the entire project or causes the organization to miss opportunities. Decisions may be delayed and delayed meetings disrupt project schedules . However chasing people for responses distracts people from more productive work. In case…   Read more»